Long-term Effects of Laser Refractive Surgery

Phase 4

Completed

• Conditions: Myopia

• Registration Number: NCT00350246
• Lead Sponsor: Mayo Clinic

Brief Summary

This study will determine if there are short- and long-term postoperative differences in visual and corneal outcomes between different laser refractive surgical procedures.

Detailed Description

We will measure postoperative differences in visual acuity, contrast sensitivity, corneal light scatter, density of keratocytes and subbasal nerves, corneal sensitivity, corneal topography and wavefront between PRK performed with epithelial removal by a laser or by a rotary brush and between LASIK performed by using a microkeratome or by using a femtosecond laser. Measurements will be made at baseline and at intervals over 5 postoperative years in 21 LASIK patients, 20 PRK patients, and 20 unoperated controls.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2006-07-07
• Study First Submitted QC: 2006-07-07
• Study First Posted: 2006-07-10
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-27
• Last Update Posted: 2010-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
keratocyte density at 5 years
nerve density at 5 years

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States