Clinical trial NCT04219891: WaveLight® EX500 Excimer Laser System for the Correction of Myopia Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap
Official title: Pivotal Trial of WaveLight® EX500 Excimer Laser System for the Correction of Myopia With and Without Astigmatism Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: LASIK
Ray Tracing
Myopia
Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-01-07
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
measure: Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability
timeFrame: Month 1, Month 3
measure: Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability
timeFrame: Month 1, Month 3
measure: Percentage of Eyes That Achieve Refractive Stability Assessed as Change From Baseline in MRSE of Equal to or Less Than 1.0 D
timeFrame: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
measure: Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability
timeFrame: Day -30 to -1 (preoperative), up to Month 3
measure: Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability
timeFrame: Day -30 to -1 (preoperative), up to Month 3
measure: 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
timeFrame: Day -30 to -1 (preoperative), up to Month 3
measure: Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability
timeFrame: Up to Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Alcon Investigative Site
state: California
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Chevy Chase
country: United States
facility: Alcon Investigative Site
state: Maryland
city: Kansas City
country: United States
facility: Alcon Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Alcon Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Alcon Investigative Site
state: Nebraska
city: Mount Pleasant
country: United States
facility: Alcon Investigative Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Alcon Investigative Site
state: South Dakota
city: Dallas
country: United States
facility: Alcon Investigative Site
state: Texas
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Trial Lead, Surgical
role: STUDY_DIRECTOR
References: