Refractive Error
Conditions
Keywords
nearsighted, astigmatism, LASIK, refractive surgery, WaveLight
Brief summary
The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.
Interventions
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
PROCEDURELASIK surgery
Surgical procedure for treating refractive error based on corneal reshaping
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to understand and sign an informed consent form. * Have refractive error (in both eyes) that requires refractive surgery. * Willing to undergo LASIK surgery using the Wavelight® Refractive Suite. * Myopia between 0.00 to -12.0 Diopters pre-operatively. * Astigmatism between 0.00 to +6.00 Diopters pre-operatively. * Willing and able to attend post-operative examinations per protocol schedule. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Participation in a clinical study within the last 30 days. * History of previous corneal surgery in either eye. * Multifocal ablations in either eye. * PRK or PTK surgery in either eye. * Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc. * Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study. * Unable to discontinue contact lens wear as specified in protocol. * History of Herpes simplex or Herpes zoster keratitis. * Active ocular rosacea. * Lyme disease. * Severe ocular allergies. * Other medical conditions and use of medications as specified in protocol. * Pregnant or planning to become pregnant during the study. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively | Day 1 Postoperative | The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap | Operation/Surgery (Day 1) | The extent of OBL was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of flap with opaque bubble layer development during femtosecond flap creation. |
| The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively | Month 1 Postoperative | The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness. |
| Uncorrected Visual Acuity (UCVA) | Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | Visual acuity (VA) without spectacles or other visual corrective devices, was performed with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at a distance of 4 meters. UCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity. |
| Best Corrected Visual Acuity (BCVA) | Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | VA with the subjects's best spectacles or other visual corrective devices, was performed with an ETDRS chart set at a distance of 4 meters. BCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity. |
| Manifest Refraction (Sphere) | Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis. |
| Manifest Refraction (Cylinder) | Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis. |
| Mean Contrast Sensitivity (CS) | Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity. Both eyes contributed to the analysis. |
| Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters. |
| Wavefront Aberrometry | Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative | Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology. |
| Percent Response by Category: Driving at Night | Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative | As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative. |
| Incidence of Development of Opaque Bubble Layer (OBL) | Operation/Surgery (Day 1) | OBL (the collection of gas bubbles during corneal flap creation) was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of participants with opaque bubble layer development during femtosecond flap creation. |
| Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative | As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error. |
| Percent Response by Category: I Worry About my Vision | Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative | As recorded by the subject on the RSVP questionnaire |
| Percent Response by Category: My Vision is a Concern in my Daily Life | Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative | As recorded by the subject on the RSVP questionnaire |
| Corneal Curvature as Measured by Keratometry | Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | Corneal curvature as assessed by a commercially available system and measured in diopters. |
| Flap Creation Time as Documented in the Log Files | Operation/Surgery (Day 1) | The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds. |
| Corneal Topography: Q-value | Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | The Q-value (a measure of corneal asphericity) was assessed using a commercially available system. The Q-values are negative (-1 \< Q \< 0) for prolate corneas, in which the central curvature is steeper than the peripheral curvature, and positive (Q \> 0) for oblate corneas, in which the central curvature is flatter than the peripheral curvature. |
| Corneal Topography: Anterior Chamber (AC) Volume | Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | The AC volume (a measure of the shallowness of the anterior chamber) was assessed using a commercially available system. The lower the chamber volume, the more shallow the anterior chamber or the chamber angle. |
| Corneal Topography: Anterior Chamber (AC) Depth | Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | The AC depth (axial distance between the anterior surface of the cornea and the anterior surface of the lens) was assessed using a commercially available system. A higher value represents a longer distance. |
| Corneal Topography: Angles | Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative | The angles (angular measurement of the space between the iris and the lens) were assessed using a commercially available system. The higher the value, the bigger the space. |
| Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses | Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative | As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision). |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in the US and 1 study center located in Greece.
Pre-assignment details
Of the 60 enrolled subjects, 1 was exited as a screen failure prior to surgery. This reporting group includes all enrolled subjects who underwent LASIK surgery (59).
Participants by arm
| Arm | Count |
|---|---|
| WaveLight Refractive Suite Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | WaveLight Refractive Suite |
|---|---|
| Age, Continuous | 33.3 years STANDARD_DEVIATION 9.22 |
| Gender Female | 34 Participants |
| Gender Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 |
Outcome results
Primary
The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively
The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.
Time frame: Day 1 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively | Right eye (OD) | 14.996 microns | Standard Deviation 12.7509 |
| WaveLight Refractive Suite | The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively | Left eye (OS) | 13.644 microns | Standard Deviation 10.4762 |
Secondary
Best Corrected Visual Acuity (BCVA)
VA with the subjects's best spectacles or other visual corrective devices, was performed with an ETDRS chart set at a distance of 4 meters. BCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.
Time frame: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Best Corrected Visual Acuity (BCVA) | Left eye (OS) | -0.042 logMAR | Standard Deviation 0.0894 |
| WaveLight Refractive Suite | Best Corrected Visual Acuity (BCVA) | Right eye (OD) | -0.046 logMAR | Standard Deviation 0.0855 |
| WaveLight Refractive Suite | Best Corrected Visual Acuity (BCVA) | Both eyes (OU) | -0.063 logMAR | Standard Deviation 0.0814 |
| Day 1 Postoperative | Best Corrected Visual Acuity (BCVA) | Left eye (OS) | -0.027 logMAR | Standard Deviation 0.0915 |
| Day 1 Postoperative | Best Corrected Visual Acuity (BCVA) | Right eye (OD) | -0.028 logMAR | Standard Deviation 0.1097 |
| Day 1 Postoperative | Best Corrected Visual Acuity (BCVA) | Both eyes (OU) | -0.051 logMAR | Standard Deviation 0.0973 |
| Month 1 Postoperative | Best Corrected Visual Acuity (BCVA) | Left eye (OS) | -0.062 logMAR | Standard Deviation 0.0947 |
| Month 1 Postoperative | Best Corrected Visual Acuity (BCVA) | Right eye (OD) | -0.064 logMAR | Standard Deviation 0.0953 |
| Month 1 Postoperative | Best Corrected Visual Acuity (BCVA) | Both eyes (OU) | -0.096 logMAR | Standard Deviation 0.0907 |
| Month 3 Postoperative | Best Corrected Visual Acuity (BCVA) | Left eye (OS) | -0.070 logMAR | Standard Deviation 0.0967 |
| Month 3 Postoperative | Best Corrected Visual Acuity (BCVA) | Right eye (OD) | -0.072 logMAR | Standard Deviation 0.0877 |
| Month 3 Postoperative | Best Corrected Visual Acuity (BCVA) | Both eyes (OU) | -0.099 logMAR | Standard Deviation 0.0863 |
| Month 6 Postoperative | Best Corrected Visual Acuity (BCVA) | Left eye (OS) | -0.086 logMAR | Standard Deviation 0.0941 |
| Month 6 Postoperative | Best Corrected Visual Acuity (BCVA) | Right eye (OD) | -0.091 logMAR | Standard Deviation 0.081 |
| Month 6 Postoperative | Best Corrected Visual Acuity (BCVA) | Both eyes (OU) | -0.111 logMAR | Standard Deviation 0.087 |
| Month 12 Postoperative | Best Corrected Visual Acuity (BCVA) | Right eye (OD) | -0.103 logMAR | Standard Deviation 0.088 |
| Month 12 Postoperative | Best Corrected Visual Acuity (BCVA) | Both eyes (OU) | -0.148 logMAR | Standard Deviation 0.0837 |
| Month 12 Postoperative | Best Corrected Visual Acuity (BCVA) | Left eye (OS) | -0.099 logMAR | Standard Deviation 0.0976 |
Secondary
Corneal Curvature as Measured by Keratometry
Corneal curvature as assessed by a commercially available system and measured in diopters.
Time frame: Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 44.7 diopter | Standard Deviation 1.78 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 43.5 diopter | Standard Deviation 1.74 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 44.0 diopter | Standard Deviation 1.6 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 43.4 diopter | Standard Deviation 1.58 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 44.1 diopter | Standard Deviation 1.72 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 44.6 diopter | Standard Deviation 1.69 |
| Day 1 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 40.5 diopter | Standard Deviation 2.49 |
| Day 1 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 39.9 diopter | Standard Deviation 2.42 |
| Day 1 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 40.1 diopter | Standard Deviation 2.42 |
| Day 1 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 39.8 diopter | Standard Deviation 2.37 |
| Day 1 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 40.6 diopter | Standard Deviation 2.59 |
| Day 1 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 40.3 diopter | Standard Deviation 2.47 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 40.2 diopter | Standard Deviation 2.25 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 40.5 diopter | Standard Deviation 2.32 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 40.7 diopter | Standard Deviation 2.52 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 39.9 diopter | Standard Deviation 2.43 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 39.8 diopter | Standard Deviation 2.2 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 40.3 diopter | Standard Deviation 2.46 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 40.8 diopter | Standard Deviation 2.51 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 40.0 diopter | Standard Deviation 2.36 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 39.9 diopter | Standard Deviation 2.31 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 40.8 diopter | Standard Deviation 2.37 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 40.4 diopter | Standard Deviation 2.42 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 40.4 diopter | Standard Deviation 2.33 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 40.0 diopter | Standard Deviation 2.26 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 40.4 diopter | Standard Deviation 2.3 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 40.1 diopter | Standard Deviation 2.34 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 40.5 diopter | Standard Deviation 2.39 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 40.8 diopter | Standard Deviation 2.35 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 40.8 diopter | Standard Deviation 2.47 |
Secondary
Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)
The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters.
Time frame: Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Right eye (OD) | 8.4 millimeters | Standard Deviation 0.25 |
| WaveLight Refractive Suite | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Left eye (OS) | 8.4 millimeters | Standard Deviation 0.27 |
| Day 1 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Right eye (OD) | 8.4 millimeters | Standard Deviation 0.25 |
| Day 1 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Left eye (OS) | 8.4 millimeters | Standard Deviation 0.27 |
| Month 1 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Right eye (OD) | 8.4 millimeters | Standard Deviation 0.24 |
| Month 1 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Left eye (OS) | 8.4 millimeters | Standard Deviation 0.26 |
| Month 3 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Right eye (OD) | 8.4 millimeters | Standard Deviation 0.25 |
| Month 3 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Left eye (OS) | 8.4 millimeters | Standard Deviation 0.27 |
| Month 6 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Right eye (OD) | 8.4 millimeters | Standard Deviation 0.25 |
| Month 6 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Left eye (OS) | 8.4 millimeters | Standard Deviation 0.27 |
| Month 12 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Right eye (OD) | 8.4 millimeters | Standard Deviation 0.25 |
| Month 12 Postoperative | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) | Left eye (OS) | 8.4 millimeters | Standard Deviation 0.27 |
Secondary
Corneal Topography: Angles
The angles (angular measurement of the space between the iris and the lens) were assessed using a commercially available system. The higher the value, the bigger the space.
Time frame: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Corneal Topography: Angles | Day 1 Postoperative, n=116 | 41.07 degrees | Standard Deviation 6.612 |
| WaveLight Refractive Suite | Corneal Topography: Angles | Month 1 Postoperative, n=118 | 40.63 degrees | Standard Deviation 6.155 |
| WaveLight Refractive Suite | Corneal Topography: Angles | Month 3 Postoperative, n=118 | 41.09 degrees | Standard Deviation 6.155 |
| WaveLight Refractive Suite | Corneal Topography: Angles | Month 6 Postoperative, n=118 | 40.81 degrees | Standard Deviation 6.141 |
| WaveLight Refractive Suite | Corneal Topography: Angles | Month 12 Postoperative, n=118 | 40.74 degrees | Standard Deviation 6.133 |
Secondary
Corneal Topography: Anterior Chamber (AC) Depth
The AC depth (axial distance between the anterior surface of the cornea and the anterior surface of the lens) was assessed using a commercially available system. A higher value represents a longer distance.
Time frame: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Depth | Month 12 Postoperative, n=118 | 3.16 millimeters | Standard Deviation 0.276 |
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Depth | Day 1 Postoperative, n=116 | 3.43 millimeters | Standard Deviation 0.37 |
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Depth | Month 1 Postoperative, n=117 | 3.43 millimeters | Standard Deviation 0.349 |
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Depth | Month 3 Postoperative, n=118 | 3.38 millimeters | Standard Deviation 0.352 |
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Depth | Month 6 Postoperative, n=118 | 3.18 millimeters | Standard Deviation 0.272 |
Secondary
Corneal Topography: Anterior Chamber (AC) Volume
The AC volume (a measure of the shallowness of the anterior chamber) was assessed using a commercially available system. The lower the chamber volume, the more shallow the anterior chamber or the chamber angle.
Time frame: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Volume | Day 1 Postoperative, n=116 | 189.98 millimeters cubed | Standard Deviation 30.439 |
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Volume | Month 1 Postoperative, n=118 | 195.25 millimeters cubed | Standard Deviation 32.134 |
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Volume | Month 3 Postoperative, n=118 | 192.91 millimeters cubed | Standard Deviation 31.156 |
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Volume | Month 6 Postoperative, n=118 | 191.92 millimeters cubed | Standard Deviation 32.985 |
| WaveLight Refractive Suite | Corneal Topography: Anterior Chamber (AC) Volume | Month 12 Postoperative, n=118 | 192.64 millimeters cubed | Standard Deviation 33.382 |
Secondary
Corneal Topography: Q-value
The Q-value (a measure of corneal asphericity) was assessed using a commercially available system. The Q-values are negative (-1 \< Q \< 0) for prolate corneas, in which the central curvature is steeper than the peripheral curvature, and positive (Q \> 0) for oblate corneas, in which the central curvature is flatter than the peripheral curvature.
Time frame: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Corneal Topography: Q-value | Day 1 Postoperative, n=116 | -0.30 unit less | Standard Deviation 0.661 |
| WaveLight Refractive Suite | Corneal Topography: Q-value | Month 1 Postoperative, n=118 | -0.31 unit less | Standard Deviation 0.652 |
| WaveLight Refractive Suite | Corneal Topography: Q-value | Month 3 Postoperative, n=118 | -0.06 unit less | Standard Deviation 0.769 |
| WaveLight Refractive Suite | Corneal Topography: Q-value | Month 6 Postoperative, n=118 | 0.10 unit less | Standard Deviation 0.752 |
| WaveLight Refractive Suite | Corneal Topography: Q-value | Month 12 Postoperative, n=118 | 0.02 unit less | Standard Deviation 0.748 |
Secondary
Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap
The extent of OBL was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of flap with opaque bubble layer development during femtosecond flap creation.
Time frame: Operation/Surgery (Day 1)
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap | Right eye (OD) | 8.9 percentage of flap | Standard Deviation 7.59 |
| WaveLight Refractive Suite | Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap | Left eye (OS) | 11.1 percentage of flap | Standard Deviation 6.94 |
Secondary
Flap Creation Time as Documented in the Log Files
The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds.
Time frame: Operation/Surgery (Day 1)
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Flap Creation Time as Documented in the Log Files | Right eye (OD) | 34.864 seconds | Standard Deviation 7.3001 |
| WaveLight Refractive Suite | Flap Creation Time as Documented in the Log Files | Left eye (OS) | 33.220 seconds | Standard Deviation 7.755 |
Secondary
Incidence of Development of Opaque Bubble Layer (OBL)
OBL (the collection of gas bubbles during corneal flap creation) was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of participants with opaque bubble layer development during femtosecond flap creation.
Time frame: Operation/Surgery (Day 1)
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WaveLight Refractive Suite | Incidence of Development of Opaque Bubble Layer (OBL) | Right eye (OD) | 20.3 percentage of participants |
| WaveLight Refractive Suite | Incidence of Development of Opaque Bubble Layer (OBL) | Left eye (OS) | 35.6 percentage of participants |
Secondary
Manifest Refraction (Cylinder)
A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.
Time frame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Manifest Refraction (Cylinder) | Month 1 Postoperative | -0.15 Diopters | Standard Deviation 0.236 |
| WaveLight Refractive Suite | Manifest Refraction (Cylinder) | Baseline/Screening (Day 0) | -0.95 Diopters | Standard Deviation 0.847 |
| WaveLight Refractive Suite | Manifest Refraction (Cylinder) | Month 3 Postoperative | -0.15 Diopters | Standard Deviation 0.251 |
| WaveLight Refractive Suite | Manifest Refraction (Cylinder) | Month 6 Postoperative | -0.16 Diopters | Standard Deviation 0.242 |
| WaveLight Refractive Suite | Manifest Refraction (Cylinder) | Month 12 Postoperative | -0.17 Diopters | Standard Deviation 0.323 |
Secondary
Manifest Refraction (Sphere)
A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.
Time frame: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Manifest Refraction (Sphere) | Baseline/Screening (Day 0) | -4.254 Diopters | Standard Deviation 2.334 |
| WaveLight Refractive Suite | Manifest Refraction (Sphere) | Day 1 Postoperative | -0.347 Diopters | Standard Deviation 0.4174 |
| WaveLight Refractive Suite | Manifest Refraction (Sphere) | Month 1 Postoperative | -0.186 Diopters | Standard Deviation 0.3304 |
| WaveLight Refractive Suite | Manifest Refraction (Sphere) | Month 3 Postoperative | -0.153 Diopters | Standard Deviation 0.3049 |
| WaveLight Refractive Suite | Manifest Refraction (Sphere) | Month 6 Postoperative | -0.167 Diopters | Standard Deviation 0.3253 |
| WaveLight Refractive Suite | Manifest Refraction (Sphere) | Month 12 Postoperative | -0.165 Diopters | Standard Deviation 0.319 |
Secondary
Mean Contrast Sensitivity (CS)
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity. Both eyes contributed to the analysis.
Time frame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS A (corrected), n=59, 59, 59, 59, 59 | 1.970 logCS | Standard Deviation 0.1576 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=29, 58, 57, 56, 58 | 0.321 logCS | Standard Deviation 0.5745 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=28, 59, 58, 59, 58 | 0.687 logCS | Standard Deviation 0.4789 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS C (corrected), n=57, 58, 57, 56, 58 | 1.262 logCS | Standard Deviation 0.2657 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS C (corrected), n=59, 59, 58, 59, 58 | 1.706 logCS | Standard Deviation 0.2716 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=31, 59, 59, 59, 59 | 0.872 logCS | Standard Deviation 0.5604 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS B (corrected), n=59, 59, 59, 59, 59 | 2.074 logCS | Standard Deviation 0.1779 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=30, 59, 59, 59, 59 | 0.986 logCS | Standard Deviation 0.4934 |
| Day 1 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected), n=59, 59, 58, 59, 58 | 1.815 logCS | Standard Deviation 0.2017 |
| Day 1 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected), n=57, 58, 57, 56, 58 | 1.338 logCS | Standard Deviation 0.2713 |
| Day 1 Postoperative | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=30, 59, 59, 59, 59 | 2.080 logCS | Standard Deviation 0.1427 |
| Day 1 Postoperative | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=28, 59, 58, 59, 58 | 1.802 logCS | Standard Deviation 0.2096 |
| Day 1 Postoperative | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=31, 59, 59, 59, 59 | 1.996 logCS | Standard Deviation 0.1219 |
| Day 1 Postoperative | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=29, 58, 57, 56, 58 | 1.317 logCS | Standard Deviation 0.2619 |
| Day 1 Postoperative | Mean Contrast Sensitivity (CS) | CS A (corrected), n=59, 59, 59, 59, 59 | 1.993 logCS | Standard Deviation 0.131 |
| Day 1 Postoperative | Mean Contrast Sensitivity (CS) | CS B (corrected), n=59, 59, 59, 59, 59 | 2.112 logCS | Standard Deviation 0.1502 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=30, 59, 59, 59, 59 | 2.087 logCS | Standard Deviation 0.1571 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=29, 58, 57, 56, 58 | 1.321 logCS | Standard Deviation 0.2485 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected), n=59, 59, 58, 59, 58 | 1.813 logCS | Standard Deviation 0.197 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS B (corrected), n=59, 59, 59, 59, 59 | 2.100 logCS | Standard Deviation 0.1424 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=28, 59, 58, 59, 58 | 1.802 logCS | Standard Deviation 0.2009 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS A (corrected), n=59, 59, 59, 59, 59 | 2.003 logCS | Standard Deviation 0.0967 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=31, 59, 59, 59, 59 | 1.971 logCS | Standard Deviation 0.1249 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected), n=57, 58, 57, 56, 58 | 1.332 logCS | Standard Deviation 0.2491 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=30, 59, 59, 59, 59 | 2.148 logCS | Standard Deviation 0.1428 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=29, 58, 57, 56, 58 | 1.369 logCS | Standard Deviation 0.2517 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected), n=59, 59, 58, 59, 58 | 1.848 logCS | Standard Deviation 0.2211 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS A (corrected), n=59, 59, 59, 59, 59 | 2.025 logCS | Standard Deviation 0.1424 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=31, 59, 59, 59, 59 | 2.006 logCS | Standard Deviation 0.1585 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected), n=57, 58, 57, 56, 58 | 1.388 logCS | Standard Deviation 0.2501 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=28, 59, 58, 59, 58 | 1.833 logCS | Standard Deviation 0.2259 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS B (corrected), n=59, 59, 59, 59, 59 | 2.180 logCS | Standard Deviation 0.1243 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected), n=57, 58, 57, 56, 58 | 1.422 logCS | Standard Deviation 0.2292 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=31, 59, 59, 59, 59 | 2.046 logCS | Standard Deviation 0.146 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=28, 59, 58, 59, 58 | 1.866 logCS | Standard Deviation 0.1727 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=29, 58, 57, 56, 58 | 1.396 logCS | Standard Deviation 0.2379 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS A (corrected), n=59, 59, 59, 59, 59 | 2.076 logCS | Standard Deviation 0.1126 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS B (corrected), n=59, 59, 59, 59, 59 | 2.172 logCS | Standard Deviation 0.1545 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected), n=59, 59, 58, 59, 58 | 1.897 logCS | Standard Deviation 0.1538 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=30, 59, 59, 59, 59 | 2.163 logCS | Standard Deviation 0.1588 |
Secondary
Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses
As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).
Time frame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WaveLight Refractive Suite | Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses | 2.7 units on a scale | Standard Deviation 1.42 |
| Day 1 Postoperative | Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses | 9.0 units on a scale | Standard Deviation 1.03 |
| Month 1 Postoperative | Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses | 9.3 units on a scale | Standard Deviation 0.82 |
| Month 3 Postoperative | Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses | 9.2 units on a scale | Standard Deviation 1.06 |
Secondary
Percent Response by Category: Driving at Night
As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative.
Time frame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 1 | 0.0 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 0 | 49.1 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 5 | 47.4 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 3 | 1.8 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 1 | 35.1 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 2 | 12.3 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 2 | 0.0 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 0 | 3.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 3 | 1.8 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 0 | 33.3 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 1 | 42.1 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 2 | 40.4 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 4 | 17.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 5 | 1.8 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 3 | 7.0 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 4 | 5.3 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 4 | 0.0 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 5 | 1.8 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 4 | 1.7 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 3 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 1 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 0 | 100.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 3 | 6.8 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 5 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 4 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 1 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 5 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 2 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 2 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 1 | 66.1 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 0 | 6.8 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 5 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 4 | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 0 | 100.0 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 2 | 18.6 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 3 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 2 | 13.6 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 4 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 5 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 0 | 100.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 1 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 2 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 3 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 4 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With glasses, 5 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 0 | 100.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 1 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 2 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 3 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 4 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 5 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 0 | 5.1 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 1 | 76.3 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 3 | 5.1 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With glasses, 4 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With glasses, 3 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 2 | 6.8 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 4 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With glasses, 2 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With glasses, 1 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 3 | 3.4 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 5 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With glasses, 0 | 100.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 5 | 1.7 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 1 | 79.7 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 1 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 0 | 5.1 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 2 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 0 | 100.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With glasses, 5 | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 4 | 3.4 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 3 | 0.0 percentage of subjects |
Secondary
Percent Response by Category: I Worry About my Vision
As recorded by the subject on the RSVP questionnaire
Time frame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Rarely | 33.9 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Never | 15.3 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Always | 1.7 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Sometimes | 32.2 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Often | 16.9 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: I Worry About my Vision | Sometimes | 8.5 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: I Worry About my Vision | Often | 8.5 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: I Worry About my Vision | Always | 1.7 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: I Worry About my Vision | Never | 27.1 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: I Worry About my Vision | Rarely | 54.2 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Sometimes | 11.9 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Never | 50.8 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Rarely | 30.5 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Often | 5.1 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Always | 1.7 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: I Worry About my Vision | Often | 5.1 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: I Worry About my Vision | Rarely | 23.7 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: I Worry About my Vision | Never | 55.9 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: I Worry About my Vision | Sometimes | 13.6 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: I Worry About my Vision | Always | 1.7 percentage of subjects |
Secondary
Percent Response by Category: My Vision is a Concern in my Daily Life
As recorded by the subject on the RSVP questionnaire
Time frame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WaveLight Refractive Suite | Percent Response by Category: My Vision is a Concern in my Daily Life | Often | 8.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: My Vision is a Concern in my Daily Life | Rarely | 28.8 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: My Vision is a Concern in my Daily Life | Always | 25.4 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: My Vision is a Concern in my Daily Life | Sometimes | 33.9 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: My Vision is a Concern in my Daily Life | Never | 3.4 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Sometimes | 6.8 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Often | 6.8 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Always | 10.2 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Rarely | 49.2 percentage of subjects |
| Day 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Never | 27.1 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Sometimes | 5.1 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Never | 44.1 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Rarely | 30.5 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Often | 3.4 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Always | 16.9 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Often | 6.8 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Rarely | 22.0 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Never | 50.8 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Sometimes | 6.8 percentage of subjects |
| Month 3 Postoperative | Percent Response by Category: My Vision is a Concern in my Daily Life | Always | 13.6 percentage of subjects |
Secondary
Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks
As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error.
Time frame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WaveLight Refractive Suite | Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | No | 67.8 percentage of subjects |
| WaveLight Refractive Suite | Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | Yes | 32.2 percentage of subjects |
| Day 1 Postoperative | Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | Yes | 0.0 percentage of subjects |
| Day 1 Postoperative | Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | No | 100.0 percentage of subjects |
| Month 1 Postoperative | Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | No | 100.0 percentage of subjects |
| Month 1 Postoperative | Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | Yes | 0.0 percentage of subjects |
| Month 3 Postoperative | Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | No | 100.0 percentage of subjects |
| Month 3 Postoperative | Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks | Yes | 0.0 percentage of subjects |
Secondary
The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively
The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.
Time frame: Month 1 Postoperative
Population: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively | Right eye (OD) | 8.638 microns | Standard Deviation 5.5177 |
| WaveLight Refractive Suite | The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively | Left eye (OS) | 8.207 microns | Standard Deviation 4.7564 |
Secondary
Uncorrected Visual Acuity (UCVA)
Visual acuity (VA) without spectacles or other visual corrective devices, was performed with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at a distance of 4 meters. UCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.
Time frame: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Uncorrected Visual Acuity (UCVA) | Left eye (OS) | 1.086 logMAR | Standard Deviation 0.3849 |
| WaveLight Refractive Suite | Uncorrected Visual Acuity (UCVA) | Both eyes (OU) | 1.024 logMAR | Standard Deviation 0.4289 |
| WaveLight Refractive Suite | Uncorrected Visual Acuity (UCVA) | Right eye (OD) | 1.078 logMAR | Standard Deviation 0.4042 |
| Day 1 Postoperative | Uncorrected Visual Acuity (UCVA) | Both eyes (OU) | -0.011 logMAR | Standard Deviation 0.1118 |
| Day 1 Postoperative | Uncorrected Visual Acuity (UCVA) | Right eye (OD) | 0.043 logMAR | Standard Deviation 0.1469 |
| Day 1 Postoperative | Uncorrected Visual Acuity (UCVA) | Left eye (OS) | 0.038 logMAR | Standard Deviation 0.1182 |
| Month 1 Postoperative | Uncorrected Visual Acuity (UCVA) | Both eyes (OU) | -0.070 logMAR | Standard Deviation 0.0853 |
| Month 1 Postoperative | Uncorrected Visual Acuity (UCVA) | Right eye (OD) | -0.021 logMAR | Standard Deviation 0.1269 |
| Month 1 Postoperative | Uncorrected Visual Acuity (UCVA) | Left eye (OS) | -0.029 logMAR | Standard Deviation 0.1131 |
| Month 3 Postoperative | Uncorrected Visual Acuity (UCVA) | Right eye (OD) | -0.024 logMAR | Standard Deviation 0.1123 |
| Month 3 Postoperative | Uncorrected Visual Acuity (UCVA) | Both eyes (OU) | -0.085 logMAR | Standard Deviation 0.0786 |
| Month 3 Postoperative | Uncorrected Visual Acuity (UCVA) | Left eye (OS) | -0.027 logMAR | Standard Deviation 0.1129 |
| Month 6 Postoperative | Uncorrected Visual Acuity (UCVA) | Left eye (OS) | -0.045 logMAR | Standard Deviation 0.1116 |
| Month 6 Postoperative | Uncorrected Visual Acuity (UCVA) | Right eye (OD) | -0.041 logMAR | Standard Deviation 0.0982 |
| Month 6 Postoperative | Uncorrected Visual Acuity (UCVA) | Both eyes (OU) | -0.084 logMAR | Standard Deviation 0.0858 |
| Month 12 Postoperative | Uncorrected Visual Acuity (UCVA) | Both eyes (OU) | -0.134 logMAR | Standard Deviation 0.0793 |
| Month 12 Postoperative | Uncorrected Visual Acuity (UCVA) | Right eye (OD) | -0.059 logMAR | Standard Deviation 0.1269 |
| Month 12 Postoperative | Uncorrected Visual Acuity (UCVA) | Left eye (OS) | -0.067 logMAR | Standard Deviation 0.099 |
Secondary
Wavefront Aberrometry
Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.
Time frame: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Population: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Wavefront Aberrometry | Total Higher Order RMS, Right Eye | 0.37 micrometers | Standard Deviation 0.138 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Total Higher Order RMS, Left eye | 0.40 micrometers | Standard Deviation 0.246 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Spherical Aberration, Right Eye | 0.0824 micrometers | Standard Deviation 0.13093 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Spherical Aberration, Left Eye | 0.0851 micrometers | Standard Deviation 0.12651 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Coma, Right Eye | 0.2059 micrometers | Standard Deviation 0.1142 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Coma, Left Eye | 0.2040 micrometers | Standard Deviation 0.1654 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Trefoil, Right Eye | 0.1798 micrometers | Standard Deviation 0.12264 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Trefoil, Left Eye | 0.2192 micrometers | Standard Deviation 0.18534 |
| Day 1 Postoperative | Wavefront Aberrometry | Coma, Left Eye | 0.2950 micrometers | Standard Deviation 0.16431 |
| Day 1 Postoperative | Wavefront Aberrometry | Coma, Right Eye | 0.3656 micrometers | Standard Deviation 0.34574 |
| Day 1 Postoperative | Wavefront Aberrometry | Total Higher Order RMS, Left eye | 0.56 micrometers | Standard Deviation 0.293 |
| Day 1 Postoperative | Wavefront Aberrometry | Trefoil, Left Eye | 0.2330 micrometers | Standard Deviation 0.21332 |
| Day 1 Postoperative | Wavefront Aberrometry | Trefoil, Right Eye | 0.2316 micrometers | Standard Deviation 0.24752 |
| Day 1 Postoperative | Wavefront Aberrometry | Spherical Aberration, Left Eye | 0.1614 micrometers | Standard Deviation 0.20808 |
| Day 1 Postoperative | Wavefront Aberrometry | Spherical Aberration, Right Eye | 0.1399 micrometers | Standard Deviation 0.23398 |
| Day 1 Postoperative | Wavefront Aberrometry | Total Higher Order RMS, Right Eye | 0.64 micrometers | Standard Deviation 0.517 |
| Month 1 Postoperative | Wavefront Aberrometry | Trefoil, Right Eye | 0.2440 micrometers | Standard Deviation 0.22987 |
| Month 1 Postoperative | Wavefront Aberrometry | Spherical Aberration, Right Eye | 0.1646 micrometers | Standard Deviation 0.20307 |
| Month 1 Postoperative | Wavefront Aberrometry | Spherical Aberration, Left Eye | 0.1727 micrometers | Standard Deviation 0.21057 |
| Month 1 Postoperative | Wavefront Aberrometry | Coma, Right Eye | 0.3306 micrometers | Standard Deviation 0.34061 |
| Month 1 Postoperative | Wavefront Aberrometry | Coma, Left Eye | 0.2927 micrometers | Standard Deviation 0.19461 |
| Month 1 Postoperative | Wavefront Aberrometry | Trefoil, Left Eye | 0.2400 micrometers | Standard Deviation 0.22751 |
| Month 1 Postoperative | Wavefront Aberrometry | Total Higher Order RMS, Right Eye | 0.60 micrometers | Standard Deviation 0.445 |
| Month 1 Postoperative | Wavefront Aberrometry | Total Higher Order RMS, Left eye | 0.57 micrometers | Standard Deviation 0.318 |
| Month 3 Postoperative | Wavefront Aberrometry | Spherical Aberration, Right Eye | 0.1619 micrometers | Standard Deviation 0.19886 |
| Month 3 Postoperative | Wavefront Aberrometry | Spherical Aberration, Left Eye | 0.1954 micrometers | Standard Deviation 0.1835 |
| Month 3 Postoperative | Wavefront Aberrometry | Total Higher Order RMS, Left eye | 0.58 micrometers | Standard Deviation 0.375 |
| Month 3 Postoperative | Wavefront Aberrometry | Total Higher Order RMS, Right Eye | 0.65 micrometers | Standard Deviation 0.601 |
| Month 3 Postoperative | Wavefront Aberrometry | Coma, Right Eye | 0.3416 micrometers | Standard Deviation 0.27229 |
| Month 3 Postoperative | Wavefront Aberrometry | Trefoil, Left Eye | 0.2403 micrometers | Standard Deviation 0.20733 |
| Month 3 Postoperative | Wavefront Aberrometry | Trefoil, Right Eye | 0.2708 micrometers | Standard Deviation 0.51291 |
| Month 3 Postoperative | Wavefront Aberrometry | Coma, Left Eye | 0.2858 micrometers | Standard Deviation 0.18065 |