Long-term Effects of Laser Refractive Surgery

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00350246
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 62
• Location: 1
• Duration (Months): 54
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Procedure: Laser Refractive Surgery	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long-term Effects of Laser Refractive Surgery
• Study Start Date: Jul 1, 2004
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Outcome Measures

Primary Outcome Measures

1. keratocyte density at 5 years []

2. nerve density at 5 years []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Myopia 1-10 diopters No other ocular abnormalities except presbyopia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: William M. Bourne, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00350246
• Other Study ID Numbers: 66-04
• First Posted: Jul 10, 2006
• Last Update Posted: Jan 28, 2010
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Jan 28, 2010