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Clinical Trials/NCT03292419
NCT03292419
Completed
Not Applicable

A Prospective Evaluation of Topography-guided LASIK Surgery

Stanford University1 site in 1 country30 target enrollmentJune 1, 2018
ConditionsMyopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Stanford University
Enrollment
30
Locations
1
Primary Endpoint
Epithelial thickness maps
Status
Completed
Last Updated
4 years ago

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

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
March 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Edward E. Manche

Professor of Ophthalmology

Stanford University

Eligibility Criteria

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)

Study Sites (1)

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