Long-term LASIK Follow up Study

NCT ID: NCT01695642

Last Updated: 2017-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lasik Eye Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Microkeratome

mechanical microkeratome

No interventions assigned to this group

Intralase

femtosecond laser

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of follow up after surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Roni Shtein

Assistant Professor of Ophthalmology and Visual Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roni Shtein, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Kellogg Eye Center

Locations

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Kellogg Eye Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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LASIK_00049051

Identifier Type: -

Identifier Source: org_study_id

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