An interventional study of WaveLight EX500 excimer laser system with InnovEyes sightmap and LASIK in Myopia, sponsored by Alcon Research. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
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.
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 272 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-specified inclusion and exclusion criteria may apply.
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Device: WaveLight EX500 excimer laser system with InnovEyes sightmap · Procedure: LASIK · Device: 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.
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.
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
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
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
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
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
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
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
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
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
Participants were recruited from 9 investigative sites located in 1 country (US).
| Milestone | WaveLight EX500 Excimer Laser System |
|---|---|
| Started | 168 |
| Successful surgery | 168 |
| Safety analysis set (sas) | 168 |
| Full analysis set (fas) | 167 |
| Fas at refractive stability | 163 |
| Completed | 163 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Withdrawal by subject | 2 |
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 | 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 |
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 | WaveLight EX500 Excimer Laser System |
|---|---|
| Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability | 92.0 |
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 | WaveLight EX500 Excimer Laser System |
|---|---|
| Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability | 98.5 |
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 | 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 |
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 | 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 |
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 | 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 |
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 | 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 |
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.
| percentage of eyes | WaveLight EX500 Excimer Laser System |
|---|---|
| Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability | 0.0 |
Collected over Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/168 (0%) | 0/168 (0%) | 3/168 (1.8%) |
| WaveLight EX500 Excimer Laser System (Ocular) | 0/336 (0%) | 4/336 (1.2%) | 0/336 (0%) |
| WaveLight EX500 Excimer Laser System (Systemic) | 0/168 (0%) | 0/168 (0%) | 10/168 (6%) |
| Event | Pretreatment | WaveLight EX500 Excimer Laser System (Ocular) | WaveLight EX500 Excimer Laser System (Systemic) |
|---|---|---|---|
| Retinal TearEye disorders | 0/168 | 2/336 | 0/168 |
| Visual acuity reducedEye disorders | 0/168 | 2/336 | 0/168 |
| Corneal opacityEye disorders | 0/168 | 1/336 | 0/168 |
| Event | Pretreatment | WaveLight EX500 Excimer Laser System (Ocular) | WaveLight EX500 Excimer Laser System (Systemic) |
|---|---|---|---|
| Corona virus infectionInfections and infestations | 3/168 | 0/336 | 10/168 |
Full Analysis Set
| Age, Continuous(years) | WaveLight EX500 Excimer Laser System |
|---|---|
| Mean | 33.3 ± 6.98 |
| Sex: Female, Male(Participants) | WaveLight EX500 Excimer Laser System |
|---|---|
| Female | 105 |
| Male | 62 |
| Race/Ethnicity, Customized(Participants) | WaveLight EX500 Excimer Laser System |
|---|---|
| White | 128 |
| Black or African American | 10 |
| American Indian or Alaska Native | 1 |
| Asian | 16 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Multi-Racial | 2 |
| Other | 9 |
| Race/Ethnicity, Customized(Participants) | WaveLight EX500 Excimer Laser System |
|---|---|
| Hispanic or Latino | 23 |
| Not Hispanic or Latino | 143 |
| Not reported | 1 |
| Unknown | 0 |
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