A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Stanford University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Percentage of eyes achieving uncorrected visual acuity
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.
Detailed Description
The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism Three FDA-approved laser devices are being used for the study. Two excimer lasers are being used for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway. One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway. All three lasers are being used according to their approved indications.
Investigators
Edward E. Manche
Professor of Ophthalmology
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of eyes achieving uncorrected visual acuity
Time Frame: One year
Percentage of eyes achieving an uncorrected visual acuity of 20/40, 20/25 ,20/20, 20/16, 20/12.5 and 20/10 at post-operative month twelve
Secondary Outcomes
- Percentage of eyes with a change in two or more lines of corrected visual acuity(One year)
- Patient Quality of Vision(One year)
- Predictability(One year)
- Change in corneal epithelial thickness(One year)