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

Abbott

Status and phase

Completed

Phase 3

Conditions

Myopia

Treatments

Device: LASIK correction of myopic refractive errors

Study type

Interventional

Funder types

Industry

Identifiers

NCT01663363

STAR-110-IDMY

Details and patient eligibility

About

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

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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