NCT05588882

Wavefront-guided vs. Topography-guided LASIK

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 22 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia

Interventions

Type	Name	Description
PROCEDURE	Wavefront-guided LASIK	Topography-guided utilizes topography mapping to perform the ablation
PROCEDURE	Wavefront-guided	Wavefront-guided utilizes aberrometry to perform the ablation

Timeline

• Start date: 2022-10-19
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2022-10-20
• Last updated: 2024-09-26

Locations

1 site across 1 country: United States