Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors

Phase 3

Completed

• Conditions: Myopia

• Registration Number: NCT01663363
• Lead Sponsor: Abbott Medical Optics

Brief Summary

The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-13
• Primary Completion: 2014-03
• Results First Submitted: 2015-05-28
• Results First Submitted QC: 2015-06-09
• Results First Posted: 2015-06-26
• Study Completion: 2015-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• 18 years of age or greater
• Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
• Uncorrected visual acuity (UCVA) of 20/40 or worse
• Less than 0.75D difference between cycloplegic and manifest refraction sphere.
• Demonstration of refractive stability
• Anticipated post-operative stromal bed thickness of at least 250 microns
• Willing and capable of returning for follow-up examinations for the duration of the study.

Exclusion Criteria

• Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
• Concurrent use of topical or systemic medications that may impair healing
• History of any medical conditions that could affect wound healing
• History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
• Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
• Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)	6 Months

Secondary Outcome Measures

Name	Time	Method
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better	6 Months