WaveLight® EX500 Excimer Laser System for the Correction of Myopia Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT04219891
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-07
• Study Start: 2020-03-09
• Primary Completion: 2022-11-09
• Study Completion: 2022-11-09
• Disposition First Submitted: 2023-11-02
• Disposition First Posted: 2023-11-07
• Status Verified: 2025-03
• Results First Submitted: 2025-03-19
• Results First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Results First Posted: 2025-04-06
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Alcon Investigative Site; 🇺🇸 Dallas, Texas, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States