This trial is active, not recruiting.

Condition astigmatism
Treatment lasik
Phase phase 3
Sponsor Abbott Medical Optics
Start date December 2012
End date February 2018
Trial size 126 participants
Trial identifier NCT01675492, STAR-112-IDMA


To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System

Primary Outcomes

Line loss of less than two lines for Best Spectacle Corrected Visual Acuity (BSCVA)
time frame: 9 Months

Secondary Outcomes

Uncorrected Visual Acuity (UCVA) of 20/40 or better
time frame: 9 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - At least 18 years of age at the time of pre-operative exam - Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better - Demonstration of refractive stability - Anticipated post-operative stromal bed thickness of at lest 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 Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Abbott Medical Optics.