Long-term LASIK Follow up Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Roni Shtein, University of Michigan
ClinicalTrials.gov Identifier:
NCT01695642
First received: September 26, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed for correction of myopia. There are very few studies that have been performed to evaluate long-term outcomes after LASIK.

In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability of visual outcomes and long-term effect on corneal morphology with in vivo confocal microscopy. Clinical and corneal morphology outcomes will also be compared between patients who had flaps created with the microkeratome and femtosecond laser.


Condition
Lasik Eye Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser

Further study details as provided by University of Michigan:

Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Microkeratome
Intralase

Detailed Description:

Volunteers will be eligible for enrollment into the study if have had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior.

A complete ophthalmic examination and corneal confocal microscopy will be performed. The study visit will take approximately one hour. Volunteers will be compensated $20 for their participation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All subjects who had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 2002 to 2005.

Criteria

Inclusion Criteria:

  • lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of follow up after surgery

Exclusion Criteria:

  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: NCT01695642

Contacts
Contact: Munira Hussain, MS 734-647-8397 hussain@umich.edu

Locations
United States, Michigan
Kellogg Eye Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Munira Hussain, MS    734-647-8397    hussain@umich.edu   
Principal Investigator: Roni Shtein, MD, MS         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Roni Shtein, Assistant Professor of Ophthalmology and Visual Sciences, University of Michigan
ClinicalTrials.gov Identifier: NCT01695642     History of Changes
Other Study ID Numbers: LASIK_00049051
Study First Received: September 26, 2012
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
lasik, intralase, microkeratome

ClinicalTrials.gov processed this record on October 16, 2014