Long-term Effects of Laser Refractive Surgery

NCT ID: NCT00350246

Last Updated: 2010-01-28

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

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-01-31

Brief Summary

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This study will determine if there are short- and long-term postoperative differences in visual and corneal outcomes between different laser refractive surgical procedures.

Detailed Description

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We will measure postoperative differences in visual acuity, contrast sensitivity, corneal light scatter, density of keratocytes and subbasal nerves, corneal sensitivity, corneal topography and wavefront between PRK performed with epithelial removal by a laser or by a rotary brush and between LASIK performed by using a microkeratome or by using a femtosecond laser. Measurements will be made at baseline and at intervals over 5 postoperative years in 21 LASIK patients, 20 PRK patients, and 20 unoperated controls.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Laser Refractive Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Myopia 1-10 diopters No other ocular abnormalities except presbyopia
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Principal Investigators

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William M. Bourne, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Patel SV, McLaren JW, Kittleson KM, Bourne WM. Subbasal nerve density and corneal sensitivity after laser in situ keratomileusis: femtosecond laser vs mechanical microkeratome. Arch Ophthalmol. 2010 Nov;128(11):1413-9. doi: 10.1001/archophthalmol.2010.253.

Reference Type DERIVED
PMID: 21060042 (View on PubMed)

Calvo R, McLaren JW, Hodge DO, Bourne WM, Patel SV. Corneal aberrations and visual acuity after laser in situ keratomileusis: femtosecond laser versus mechanical microkeratome. Am J Ophthalmol. 2010 May;149(5):785-93. doi: 10.1016/j.ajo.2009.12.023. Epub 2010 Mar 15.

Reference Type DERIVED
PMID: 20227675 (View on PubMed)

Other Identifiers

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66-04

Identifier Type: -

Identifier Source: org_study_id

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