This trial is active, not recruiting.

Condition myopia
Treatment lasik correction of myopic refractive errors
Phase phase 3
Sponsor Abbott Medical Optics
Start date August 2012
End date August 2014
Trial size 345 participants
Trial identifier NCT01663363, STAR-110-IDMY


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
lasik correction of myopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System

Primary Outcomes

Line loss for Best Corrected Visual Acuity (BSCVA)
time frame: 6 Months

Secondary Outcomes

Uncorrected Visual Acuity (VA) 20/40 or better
time frame: 6 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Abbott Medical Optics.