N/A
N=168
WaveLight® EX500 Excimer Laser System for the Correction of Myopia Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT04219891 ↗Enrolled (actual)
168
Serious AEs
0.6%
Results posted
Apr 2025
Primary outcome: 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 — 100.0 percentage of eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WaveLight EX500 excimer laser system with InnovEyes sightmap (Device); LASIK (Procedure); InnovEyes sightmap (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
100.0 | — |
| PRIMARY Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability |
92.0 | — |
| PRIMARY Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability |
98.5 | — |
| PRIMARY 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 | — |
| PRIMARY Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability |
0.0 | — |
| PRIMARY Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability |
— | — |
| 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 |
0.0 | — |
| PRIMARY Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability |
0.0 | — |
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.
Eligibility 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 exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04219891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.