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Long-term LASIK Follow up Study (LASIK)

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ClinicalTrials.gov Identifier: NCT01695642
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Roni Shtein, University of Michigan

Brief Summary:

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 or disease
Lasik Eye Surgery

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.


Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser
Study Start Date : June 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2016

Group/Cohort
Microkeratome
mechanical microkeratome
Intralase
femtosecond laser



Primary Outcome Measures :
  1. Compare flap creation with mikrokeratome and Intralase [ Time Frame: 8 to 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:


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 ClinicalTrials.gov identifier (NCT number): NCT01695642


Locations
United States, Michigan
Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Roni Shtein, MD, MS University of Michigan Kellogg Eye Center

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
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

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