Phase 3 N=170 Treatment

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

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT01663363 ↗

Enrolled (actual)

170

Serious AEs

1.5%

Results posted

Jun 2015

Primary outcome: Primary: Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) — 0 percentage of eyes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LASIK correction of myopic refractive errors (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Optics
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)	—	—
SECONDARY Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better	98.2	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01663363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.