Wavefront-guided vs. Topography-guided LASIK

Not Applicable

Active, not recruiting

• Conditions: Myopia
• Interventions: Procedure: Wavefront-guided LASIK; Procedure: Wavefront-guided

• Registration Number: NCT05588882
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study Start: 2022-10-19
• Study First Posted: 2022-10-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wavefront-guided LASIK	Wavefront-guided LASIK	Wavefront-guided LASIK for myopia and myopic astigmatism
Topography-guided LASIK	Wavefront-guided	Topography-guided LASIK for myopia and myopic astigmatism

Primary Outcome Measures

Name	Time	Method
Percentage of eyes achieving uncorrected visual acuity	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 Outcome Measures

Name	Time	Method
Percentage of eyes with a change in two or more lines of corrected visual acuity	One year	Percentage of eyes gaining or losing two or more lines of corrected visual acuity Percentage of eyes gaining or losing 2 or more lines of corrected distance visual acuity
Patient Quality of Vision	One year	Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK
Predictability	One year	Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected
Change in corneal epithelial thickness	One year	We will be measuring the average change in central corneal epithelial thickness from preoperative to post-operative month12 in eyes undergoing Wavefront-guided LASIK and Topography-guided LASIK

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States