Refractive Error
Conditions
Keywords
nearsighted, farsighted, astigmatism, LASIK, refractive surgery, WaveLight
Brief summary
The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).
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. * History of dry eye that is unresponsive to treatment. * 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 |
|---|---|---|
| Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA | Month 1 | Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Manifest Refraction (Sphere) | Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative | Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean. |
| Mean Manifest Refraction (Cylinder) | Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative | Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean. |
| Mean Laser Treatment Time | Day 0 (surgery) | Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. |
| Mean Total Laser Treatment Time | Day 0 (surgery) | Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye. |
| Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses | Baseline (Day 0), Month 1 Postoperative, Month 6 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). |
| Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative | As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses. |
| Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative | The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. |
| Percent Response by Category: My Vision Is a Concern in My Daily Life | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative | As recorded by the subject on the RSVP questionnaire |
| Percent Response by Category: Driving at Night | Baseline (Day 0), Month 1 Postoperative, Month 6 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. |
| Mean Contrast Sensitivity (CS) | Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 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. |
| Wavefront Aberrometry | Baseline (Day 0), Month 6 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 trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology. |
| Corneal Curvature as Measured by Keratometry | Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative | Corneal curvature was assessed by a commercially available system and measured in diopters. |
| Percent Response by Category: I Worry About my Vision | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative | As recorded by the subject on the RSVP questionnaire |
Participant flow
Recruitment details
Participants were recruited from 2 study centers located in the US, 1 study center located in Ireland, and 1 study center located in Germany.
Pre-assignment details
Of the 104 enrolled participants, 7 were exited prior to surgery as screen failures. This reporting group includes all enrolled participants who underwent LASIK surgery (97).
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 | 104 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Relocated out of state | 1 |
Baseline characteristics
| Characteristic | WaveLight Refractive Suite |
|---|---|
| Age, Continuous | 31.0 years STANDARD_DEVIATION 6.9 |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 97 | 0 / 7 |
| serious Total, serious adverse events | 1 / 97 | 0 / 7 |
Outcome results
Primary
Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA
Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.
Time frame: Month 1
Population: This analysis population includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| WaveLight Refractive Suite | Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA | -0.0519 logMAR | Standard Error 0.0075 |
Secondary
Corneal Curvature as Measured by Keratometry
Corneal curvature was assessed by a commercially available system and measured in diopters.
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 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 | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 43.5 diopter | Standard Deviation 1.41 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 43.5 diopter | Standard Deviation 1.46 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 43.9 diopter | Standard Deviation 1.55 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 44.0 diopter | Standard Deviation 1.57 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 43.7 diopter | Standard Deviation 1.38 |
| WaveLight Refractive Suite | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 43.8 diopter | Standard Deviation 1.42 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 40.6 diopter | Standard Deviation 1.9 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 40.8 diopter | Standard Deviation 1.97 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 40.4 diopter | Standard Deviation 1.79 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 40.8 diopter | Standard Deviation 1.91 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 40.4 diopter | Standard Deviation 1.89 |
| Month 1 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 40.6 diopter | Standard Deviation 1.81 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 40.5 diopter | Standard Deviation 1.88 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 41.0 diopter | Standard Deviation 1.91 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 40.9 diopter | Standard Deviation 1.96 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 40.7 diopter | Standard Deviation 1.89 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 40.8 diopter | Standard Deviation 1.79 |
| Month 6 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 40.6 diopter | Standard Deviation 1.76 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Right Eye | 40.8 diopter | Standard Deviation 1.77 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | Mean K1 and K2, Left Eye | 40.7 diopter | Standard Deviation 1.84 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Left Eye | 40.5 diopter | Standard Deviation 1.83 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Left Eye | 41.0 diopter | Standard Deviation 1.93 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | K1, Right Eye | 40.6 diopter | Standard Deviation 1.76 |
| Month 3 Postoperative | Corneal Curvature as Measured by Keratometry | K2, Right Eye | 41.0 diopter | Standard Deviation 1.87 |
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.
Time frame: Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Population: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint. Here, n is the number of subjects assessed uncorrected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=84, 84, 90, 96, 95 | 0.768 logCS | Standard Deviation 0.4356 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=84, 84, 90, 96, 95 | 0.937 logCS | Standard Deviation 0.3991 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=84, 84, 90, 96, 95 | 0.623 logCS | Standard Deviation 0.3995 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=84, 84, 90, 96, 95 | 0.189 logCS | Standard Deviation 0.4188 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS A (corrected) | 1.808 logCS | Standard Deviation 0.1399 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS B (corrected) | 2.020 logCS | Standard Deviation 0.188 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS C (corrected) | 1.739 logCS | Standard Deviation 0.2095 |
| WaveLight Refractive Suite | Mean Contrast Sensitivity (CS) | CS D (corrected) | 1.281 logCS | Standard Deviation 0.2014 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=84, 84, 90, 96, 95 | 1.734 logCS | Standard Deviation 0.2065 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS B (corrected) | 2.056 logCS | Standard Deviation 0.1631 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=84, 84, 90, 96, 95 | 1.845 logCS | Standard Deviation 0.134 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=84, 84, 90, 96, 95 | 1.273 logCS | Standard Deviation 0.2059 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=84, 84, 90, 96, 95 | 2.035 logCS | Standard Deviation 0.165 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS D (corrected) | 1.311 logCS | Standard Deviation 0.2025 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS A (corrected) | 1.863 logCS | Standard Deviation 0.1485 |
| Month 1 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected) | 1.757 logCS | Standard Deviation 0.1925 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected) | 1.828 logCS | Standard Deviation 0.1517 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS D (corrected) | 1.402 logCS | Standard Deviation 0.1577 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=84, 84, 90, 96, 95 | 1.378 logCS | Standard Deviation 0.1773 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS B (corrected) | 2.116 logCS | Standard Deviation 0.1352 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=84, 84, 90, 96, 95 | 1.806 logCS | Standard Deviation 0.1734 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=84, 84, 90, 96, 95 | 2.096 logCS | Standard Deviation 0.1341 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=84, 84, 90, 96, 95 | 1.868 logCS | Standard Deviation 0.1433 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS A (corrected) | 1.900 logCS | Standard Deviation 0.13 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=84, 84, 90, 96, 95 | 2.134 logCS | Standard Deviation 0.1267 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=84, 84, 90, 96, 95 | 1.835 logCS | Standard Deviation 0.164 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=84, 84, 90, 96, 95 | 1.401 logCS | Standard Deviation 0.1517 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS A (corrected) | 1.922 logCS | Standard Deviation 0.1242 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS B (corrected) | 2.151 logCS | Standard Deviation 0.1217 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS D (corrected) | 1.427 logCS | Standard Deviation 0.1346 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=84, 84, 90, 96, 95 | 1.894 logCS | Standard Deviation 0.1168 |
| Month 3 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected) | 1.857 logCS | Standard Deviation 0.1391 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS D (uncorrected), n=84, 84, 90, 96, 95 | 1.411 logCS | Standard Deviation 0.138 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS D (corrected) | 1.432 logCS | Standard Deviation 0.1299 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS C (uncorrected), n=84, 84, 90, 96, 95 | 1.854 logCS | Standard Deviation 0.1485 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS C (corrected) | 1.876 logCS | Standard Deviation 0.1441 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS A (uncorrected), n=84, 84, 90, 96, 95 | 1.898 logCS | Standard Deviation 0.1311 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS B (corrected) | 2.148 logCS | Standard Deviation 0.1265 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS B (uncorrected), n=84, 84, 90, 96, 95 | 2.117 logCS | Standard Deviation 0.1354 |
| Month 6 Postoperative | Mean Contrast Sensitivity (CS) | CS A (corrected) | 1.917 logCS | Standard Deviation 0.1327 |
Secondary
Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT
The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number.
Time frame: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 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 Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | Right Eye | 3.958 microns | Standard Deviation 11.0173 |
| WaveLight Refractive Suite | Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | Left Eye | 3.905 microns | Standard Deviation 12.2162 |
| Month 1 Postoperative | Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | Right Eye | 3.448 microns | Standard Deviation 7.6679 |
| Month 1 Postoperative | Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | Left Eye | 3.427 microns | Standard Deviation 7.5096 |
| Month 6 Postoperative | Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | Right Eye | 3.200 microns | Standard Deviation 7.0795 |
| Month 6 Postoperative | Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | Left Eye | 2.253 microns | Standard Deviation 5.8854 |
Secondary
Mean Laser Treatment Time
Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.
Time frame: Day 0 (surgery)
Population: This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Mean Laser Treatment Time | Right eye (OD) | 9.912 seconds | Standard Deviation 3.5755 |
| WaveLight Refractive Suite | Mean Laser Treatment Time | Left eye (OS) | 9.709 seconds | Standard Deviation 3.4498 |
| Month 1 Postoperative | Mean Laser Treatment Time | Right eye (OD) | 30.161 seconds | Standard Deviation 19.1352 |
| Month 1 Postoperative | Mean Laser Treatment Time | Left eye (OS) | 29.214 seconds | Standard Deviation 16.4972 |
Secondary
Mean Manifest Refraction (Cylinder)
Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 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 Manifest Refraction (Cylinder) | -0.32 diopter | Standard Deviation 0.86 |
| Month 1 Postoperative | Mean Manifest Refraction (Cylinder) | -0.16 diopter | Standard Deviation 0.254 |
| Month 6 Postoperative | Mean Manifest Refraction (Cylinder) | -0.16 diopter | Standard Deviation 0.217 |
| Month 3 Postoperative | Mean Manifest Refraction (Cylinder) | -0.18 diopter | Standard Deviation 0.244 |
Secondary
Mean Manifest Refraction (Sphere)
Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.
Time frame: Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 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 Manifest Refraction (Sphere) | -3.672 diopter | Standard Deviation 1.982 |
| Month 1 Postoperative | Mean Manifest Refraction (Sphere) | 0.046 diopter | Standard Deviation 0.3318 |
| Month 6 Postoperative | Mean Manifest Refraction (Sphere) | 0.077 diopter | Standard Deviation 0.3474 |
| Month 3 Postoperative | Mean Manifest Refraction (Sphere) | 0.046 diopter | Standard Deviation 0.3426 |
| Month 6 Postoperative | Mean Manifest Refraction (Sphere) | 0.017 diopter | Standard Deviation 0.3383 |
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 (Day 0), Month 1 Postoperative, Month 6 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 | 3.6 units on a scale | Standard Deviation 1.71 |
| Month 1 Postoperative | Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses | 9.1 units on a scale | Standard Deviation 1.08 |
| Month 6 Postoperative | Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses | 9.4 units on a scale | Standard Deviation 0.78 |
Secondary
Mean Total Laser Treatment Time
Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye.
Time frame: Day 0 (surgery)
Population: This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Mean Total Laser Treatment Time | Right eye (OD) | 40.073 seconds | Standard Deviation 19.1612 |
| WaveLight Refractive Suite | Mean Total Laser Treatment Time | Left eye (OS) | 38.923 seconds | Standard Deviation 16.6188 |
| WaveLight Refractive Suite | Mean Total Laser Treatment Time | Both eyes | 78.996 seconds | Standard Deviation 32.6967 |
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 (Day 0), Month 1 Postoperative, Month 6 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 | With glasses, 4 | 4.2 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 0 | 4.2 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 1 | 38.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 2 | 34.4 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 3 | 18.8 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With glasses, 5 | 0.0 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 0 | 38.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 1 | 36.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 2 | 20.8 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | With contact lenses, 3 | 4.2 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 contact lenses, 5 | 0.0 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 0 | 29.2 percentage of subjects |
| 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 | Without glasses/contact lenses, 2 | 0.0 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 3 | 4.2 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 4 | 8.3 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 5 | 58.3 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 5 | 1.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 0 | 3.1 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 | Without glasses/contact lenses, 2 | 40.6 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 | Without glasses/contact lenses, 3 | 8.3 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 4 | 3.1 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 contact lenses, 4 | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 1 | 43.8 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 contact lenses, 2 | 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, 4 | 0.0 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, 5 | 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 6 Postoperative | Percent Response by Category: Driving at Night | With glasses, 5 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 0 | 100.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 1 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 2 | 21.1 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 2 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 5 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 3 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 4 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 3 | 4.2 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With contact lenses, 5 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With glasses, 0 | 100.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 0 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With glasses, 1 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With glasses, 2 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With glasses, 3 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | With glasses, 4 | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 1 | 73.7 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: Driving at Night | Without glasses/contact lenses, 4 | 1.1 percentage of subjects |
Secondary
Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore...
As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 6 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: In the Past 4 Weeks, to See Far Away, I Wore... | only glasses | 36.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | mostly glasses, sometimes contact lenses | 32.3 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | about equally, glasses and contact lenses | 17.7 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | mostly contact lenses, sometimes glasses | 11.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | only contact lenses | 1.0 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | n/a | 1.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | n/a | 99.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | only glasses | 1.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | mostly contact lenses, sometimes glasses | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | only contact lenses | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | mostly glasses, sometimes contact lenses | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | about equally, glasses and contact lenses | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | mostly glasses, sometimes contact lenses | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | about equally, glasses and contact lenses | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | n/a | 100.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | mostly contact lenses, sometimes glasses | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | only glasses | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore... | only contact lenses | 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 (Day 0), Month 1 Postoperative, Month 6 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: I Worry About my Vision | Never | 10.4 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Often | 13.5 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Sometimes | 40.6 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Always | 5.2 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: I Worry About my Vision | Rarely | 30.2 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Always | 0.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Never | 21.9 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Rarely | 51.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Sometimes | 19.8 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: I Worry About my Vision | Often | 7.3 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: I Worry About my Vision | Rarely | 33.7 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: I Worry About my Vision | Always | 0.0 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: I Worry About my Vision | Often | 2.1 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: I Worry About my Vision | Never | 52.6 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: I Worry About my Vision | Sometimes | 11.6 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 (Day 0), Month 1 Postoperative, Month 6 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: My Vision Is a Concern in My Daily Life | Often | 14.6 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: My Vision Is a Concern in My Daily Life | Sometimes | 34.4 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: My Vision Is a Concern in My Daily Life | Never | 6.3 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: My Vision Is a Concern in My Daily Life | Rarely | 34.4 percentage of subjects |
| WaveLight Refractive Suite | Percent Response by Category: My Vision Is a Concern in My Daily Life | Always | 10.4 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: My Vision Is a Concern in My Daily Life | Sometimes | 14.6 percentage of subjects |
| Month 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 | Rarely | 51.0 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: My Vision Is a Concern in My Daily Life | Often | 5.2 percentage of subjects |
| Month 1 Postoperative | Percent Response by Category: My Vision Is a Concern in My Daily Life | Always | 2.1 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: My Vision Is a Concern in My Daily Life | Always | 1.1 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: My Vision Is a Concern in My Daily Life | Often | 3.2 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: My Vision Is a Concern in My Daily Life | Never | 63.2 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: My Vision Is a Concern in My Daily Life | Sometimes | 5.3 percentage of subjects |
| Month 6 Postoperative | Percent Response by Category: My Vision Is a Concern in My Daily Life | Rarely | 27.4 percentage of subjects |
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 trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.
Time frame: Baseline (Day 0), Month 6 Postoperative
Population: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WaveLight Refractive Suite | Wavefront Aberrometry | Spherical Aberrations, Right Eye | 0.1 microns | Standard Deviation 0.27 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Total Higher Order RMS, Right Eye | 0.7 microns | Standard Deviation 0.97 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Spherical Aberrations, Left Eye | 0.1 microns | Standard Deviation 0.19 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Trifoil, Left Eye | 0.3 microns | Standard Deviation 0.79 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Coma, Right Eye | 0.3 microns | Standard Deviation 0.42 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Total Higher Order RMS, Left Eye | 0.7 microns | Standard Deviation 1.12 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Coma, Left Eye | 0.3 microns | Standard Deviation 0.43 |
| WaveLight Refractive Suite | Wavefront Aberrometry | Trifoil, Right Eye | 0.3 microns | Standard Deviation 1.02 |
| Month 1 Postoperative | Wavefront Aberrometry | Coma, Left Eye | 0.3 microns | Standard Deviation 0.19 |
| Month 1 Postoperative | Wavefront Aberrometry | Trifoil, Left Eye | 0.3 microns | Standard Deviation 0.57 |
| Month 1 Postoperative | Wavefront Aberrometry | Total Higher Order RMS, Right Eye | 0.5 microns | Standard Deviation 0.42 |
| Month 1 Postoperative | Wavefront Aberrometry | Total Higher Order RMS, Left Eye | 0.5 microns | Standard Deviation 0.42 |
| Month 1 Postoperative | Wavefront Aberrometry | Spherical Aberrations, Right Eye | 0.2 microns | Standard Deviation 0.13 |
| Month 1 Postoperative | Wavefront Aberrometry | Spherical Aberrations, Left Eye | 0.2 microns | Standard Deviation 0.17 |
| Month 1 Postoperative | Wavefront Aberrometry | Coma, Right Eye | 0.3 microns | Standard Deviation 0.27 |
| Month 1 Postoperative | Wavefront Aberrometry | Trifoil, Right Eye | 0.4 microns | Standard Deviation 0.61 |