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Clinical Trials/NCT05588882
NCT05588882
Active, not recruiting
Not Applicable

A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery

Stanford University1 site in 1 country50 target enrollmentOctober 19, 2022
ConditionsMyopia

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.

Registry
clinicaltrials.gov
Start Date
October 19, 2022
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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