Long-term Effects of Laser Refractive Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350246
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : January 28, 2010
National Institutes of Health (NIH)
Information provided by:
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.

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 Type : Interventional  (Clinical Trial)
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 : July 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Primary Outcome Measures :
  1. keratocyte density at 5 years
  2. nerve density at 5 years

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Myopia 1-10 diopters No other ocular abnormalities except presbyopia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00350246

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Principal Investigator: William M. Bourne, M.D. Mayo Clinic