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

Alcon

Status: Completed

Conditions: Myopia

Treatments: Procedure: LASIK; Device: InnovEyes sightmap; Device: WaveLight EX500 excimer laser system with InnovEyes sightmap

Study type: Interventional

Funder types: Industry

Identifiers

NCT04219891

RFP911-C001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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272 participants in 1 patient group

WaveLight EX500 excimer laser system

Experimental group

Description:

Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap

Treatment:

Device: WaveLight EX500 excimer laser system with InnovEyes sightmap

Device: InnovEyes sightmap

Procedure: LASIK