CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 272 enrolled
Drug / intervention
WaveLight EX500 excimer laser system with InnovEyes sightmap +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04219891
NCT04219891N/ACompleted
CompareCT.gov

Pivotal Trial of WaveLight® EX500 Excimer Laser System for the Correction of Myopia With and Without Astigmatism Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap

Alcon Research·interventional·Posted Jan 7, 2020·Updated Apr 6, 2025

In Brief

A clinical study evaluating WaveLight EX500 excimer laser system with InnovEyes sightmap, LASIK, and 1 other intervention for Myopia. Completed, enrolled 272 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyopia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 7, 2020
Enrollment StartMar 9, 2020
Primary CompletionNov 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.5 years ago

Interventions

WaveLight EX500 excimer laser system with InnovEyes sightmapdevice

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.

LASIKprocedure

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.

InnovEyes sightmapdevice

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