A Prospective Evaluation of Topography-guided LASIK Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Epithelial thickness maps
Study Overview
Brief Summary
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism
Detailed Description
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. The investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. In addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why UDVA and CDVA improves over time
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
N0ne
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -8.00 diopters.
- •Subjects with up to 3.00 diopters of astigmatism.
- •Subjects with a spherical equivalent of up to -9.00 diopters.
Exclusion Criteria
- •Subjects under the age of
- •Subjects with excessively thin corneas.
- •Subjects with topographic evidence of keratoconus.
- •Subjects with ectatic eye disorders.
- •Subjects with autoimmune diseases.
- •Subjects who are pregnant or nursing.
- •Subjects with more than 3.00 diopters of astigmatism
Outcomes
Primary Outcomes
Epithelial thickness maps
Time Frame: 12 months
Changes in anterior segment optical coherence tomography epithelial thickness maps.
Secondary Outcomes
- Change in refraction over time(12 months)
- Contrast visual acuity(12 months)
- Predictability(12 months)
- Changes in corrected visual acuity(12 months)
- Uncorrected distance visual acuity(12 months)
- Quality of Vision(12 months)
- Residual astigmatism levels after surgery(12 months)
Investigators
Edward E. Manche
Professor of Ophthalmology
Stanford University