Long-term LASIK Follow up Study (LASIK)

March 16, 2017 updated by: Roni Shtein, University of Michigan

Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Kellogg Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Microkeratome
mechanical microkeratome
Intralase
femtosecond laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare flap creation with mikrokeratome and Intralase
Time Frame: 8 to 10 years
8 to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Roni Shtein, MD, MS, University of Michigan Kellogg Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LASIK_00049051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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