Long-term Effects of Laser Refractive Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00350246
First received: July 7, 2006
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Myopia
Procedure: Laser Refractive Surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Effects of Laser Refractive Surgery

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • keratocyte density at 5 years
  • nerve density at 5 years

Enrollment: 62
Study Start Date: July 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Myopia 1-10 diopters No other ocular abnormalities except presbyopia

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350246

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: William M. Bourne, M.D. Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00350246     History of Changes
Other Study ID Numbers: 66-04
Study First Received: July 7, 2006
Last Updated: January 27, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 18, 2014