Myopia
Conditions
Keywords
LASIK, Ray Tracing, Myopia, Astigmatism
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the WaveLight EX500 excimer laser system for the correction of myopia with and without astigmatism using InnovEyes in conjunction with InnovEyes sightmap.
Detailed description
Qualified subjects will receive treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Day 0 Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Year 1). The primary endpoints will be assessed at refractive stability, defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. Total expected duration of subject participation is approximately 1 year. This study will be conducted in the United States.
Interventions
DEVICEWaveLight EX500 excimer laser system with InnovEyes sightmap
FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the WaveLight EX500 software will be upgraded to include the InnovEyes treatment.
PROCEDURELASIK
Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system and data obtained from the InnovEyes sightmap.
DEVICEInnovEyes sightmap
Non-contact ophthalmic diagnostic device that captures images of the eye and collects ocular data preoperatively to generate a patient-specific ablation profile for refractive correction surgery
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
Key Inclusion Criteria: * Myopia up to and including -11.00 D with or without astigmatism up to -4.50 D, with MRSE no more than -12.00 D * Best corrected photopic distance visual acuity of 20/20 or better * Uncorrected photopic distance visual acuity of 20/40 or worse * Stable refraction (within ± 0.50 D) as determined by MRSE for a minimum of 12 months prior to surgery Key
Exclusion criteria
* History or evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma (or suspect) * Previous intraocular or corneal surgery * Intent to have monovision treatment Other protocol-specified inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/40 or Better (in Eyes With Preoperative Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better) at Refractive Stability | Preoperative Visit (Day -30 to Day -1), Month 1, Month 3 | Visual acuity (VA) was assessed using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters and reported in Snellen, where 20/20 indicates normal distance eyesight. Preoperatively, VA was assessed with correction in place. Postoperatively, VA was assessed with no correction in place. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint. |
| Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability | Month 1, Month 3 | A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive Stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint. |
| Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability | Month 1, Month 3 | A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint. |
| Percentage of Eyes That Achieve Refractive Stability Assessed as Change From Baseline in MRSE of Equal to or Less Than 1.0 D | Preoperative Visit (Day -30 to Day -1), Month 1, Month 3 | A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint. |
| Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability | Day -30 to -1 (preoperative), up to Month 3 | VA was assessed using ETDRS charts at a distance of 4 meters with correction in place. BCDVA was measured in Snellen, where 20/20 indicates normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint. |
| Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability | Day -30 to -1 (preoperative), up to Month 3 | VA was assessed using ETDRS charts at a distance of 4 meters with correction in place and measured in logarithm Minimum Angle of Resolution, where each line on the letter chart represents 0.1 Snellen and 0.0 logMAR equates to 20/20 Snellen, or normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint. |
| Percentage of Eyes With Increase of Manifest Refractive Astigmatism Greater Than 2.00 Diopter (D) of Absolute Cylinder Compared to Preoperative Visit at Refractive Stability | Day -30 to -1 (preoperative), up to Month 3 | Manifest refractive astigmatism is the cylindrical portion of the subjective refraction. It is measured with ETDRS charts at a distance of 4 meters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint. |
| Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability | Up to Month 3 | An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 9 investigative sites located in 1 country (US).
Pre-assignment details
Of the 272 enrolled, 104 participants were exited prior to treatment as screen failures. This reporting group includes all subjects with attempted surgery (168 subjects / 336 eyes).
Participants by arm
| Arm | Count |
|---|---|
| WaveLight EX500 Excimer Laser System Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap | 167 |
| WaveLight EX500 Excimer Laser System Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap | 334 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | WaveLight EX500 Excimer Laser System |
|---|---|
| Age, Continuous | 33.3 years STANDARD_DEVIATION 6.98 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 23 Participants |
| Race/Ethnicity, Customized Multi-Racial | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 143 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants |
| Race/Ethnicity, Customized Other | 9 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 128 Participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 168 | 0 / 336 | 0 / 168 |
| other Total, other adverse events | 3 / 168 | 0 / 336 | 10 / 168 |
| serious Total, serious adverse events | 0 / 168 | 4 / 336 | 0 / 168 |
Outcome results
Primary
Percentage of Eyes That Achieve Refractive Stability Assessed as Change From Baseline in MRSE of Equal to or Less Than 1.0 D
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Time frame: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
Population: Consistent Cohort Analysis Set: All eyes in the FAS that have manifest refraction data at all post-operative visits from one month up to and including the visit where refractive stability is established.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes That Achieve Refractive Stability Assessed as Change From Baseline in MRSE of Equal to or Less Than 1.0 D | 99.4 percentage of eyes |
Primary
Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability
VA was assessed using ETDRS charts at a distance of 4 meters with correction in place and measured in logarithm Minimum Angle of Resolution, where each line on the letter chart represents 0.1 Snellen and 0.0 logMAR equates to 20/20 Snellen, or normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Time frame: Day -30 to -1 (preoperative), up to Month 3
Population: SAS with requisite data at Month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability | 0 percentage of eyes |
Primary
Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability
VA was assessed using ETDRS charts at a distance of 4 meters with correction in place. BCDVA was measured in Snellen, where 20/20 indicates normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Time frame: Day -30 to -1 (preoperative), up to Month 3
Population: SAS with requisite data at Month 3. Note: 1 eye was excluded from this analysis due to not having a preoperative BCDVA of 20/20 or better.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability | 0.0 percentage of eyes |
Primary
Percentage of Eyes With Increase of Manifest Refractive Astigmatism Greater Than 2.00 Diopter (D) of Absolute Cylinder Compared to Preoperative Visit at Refractive Stability
Manifest refractive astigmatism is the cylindrical portion of the subjective refraction. It is measured with ETDRS charts at a distance of 4 meters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Time frame: Day -30 to -1 (preoperative), up to Month 3
Population: SAS with requisite data at Month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With Increase of Manifest Refractive Astigmatism Greater Than 2.00 Diopter (D) of Absolute Cylinder Compared to Preoperative Visit at Refractive Stability | 0.0 percentage of eyes |
Primary
Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive Stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Time frame: Month 1, Month 3
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability | 92.0 percentage of eyes |
Primary
Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Time frame: Month 1, Month 3
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability | 98.5 percentage of eyes |
Primary
Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Time frame: Up to Month 3
Population: SAS with requisite data at Month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability | 0.0 percentage of eyes |
Primary
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/40 or Better (in Eyes With Preoperative Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better) at Refractive Stability
Visual acuity (VA) was assessed using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters and reported in Snellen, where 20/20 indicates normal distance eyesight. Preoperatively, VA was assessed with correction in place. Postoperatively, VA was assessed with no correction in place. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.
Time frame: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
Population: FAS. Note: 1 eye was excluded from this analysis due to not having a preoperative best corrected distance visual acuity (BCDVA) of 20/20 or better.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/40 or Better (in Eyes With Preoperative Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better) at Refractive Stability | 100.0 percentage of eyes |