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OpenTrials
Completed

NCT Number: NCT01695642

Long-term LASIK Follow up Study

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.

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Key information

Conditions

Lasik Eye Surgery

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

  1. Compare flap creation with mikrokeratome and Intralase

    Time frame: 8 to 10 years

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: LASIK

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Sep 28, 2012
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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