A Comparison of Photorefractive Keratectomy (PRK), PRK With Mitomycin-C and Laser Subepithelial Keratomileusis (LASEK) in the Treatment of Moderate and High Myopia

Sponsor

Walter Reed Army Medical Center (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT00415077

Collaborator

Madigan Army Medical Center (U.S. Fed), C.R.Darnall Army Medical Center (U.S. Fed), Blanchfield Army Community Hospital (U.S. Fed), Tripler Army Medical Center (U.S. Fed)

960

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to assess whether there is a significant difference in visual outcomes or corneal haze after surface ablation for moderate and high myopia in active duty service members treated with PRK, Mitomycin-C (MMC) PRK and LASEK.

Condition or Disease	Intervention/Treatment	Phase
MODERATE AND HIGH MYOPIA	Procedure: PRK Procedure: MMC PRK Procedure: LASEK	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

960 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective Comparison of Photorefractive Keratectomy (PRK), PRK With Mitomycin-C and Laser Subepithelial Keratomileusis (LASEK) in the Treatment of Moderate and High Myopia

Study Start Date :

Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 LASEK- laser-assisted subepithelial keratectomy	Procedure: MMC PRK mitomycin C PRK
Active Comparator: 3 Mitomycin C PRK	Procedure: LASEK LASEK
Active Comparator: 1 PRK- Photorefractive keratectomy	Procedure: PRK PRK

Arm

Intervention/Treatment

Active Comparator: 2

LASEK- laser-assisted subepithelial keratectomy

Procedure: MMC PRK

mitomycin C PRK

Active Comparator: 3

Mitomycin C PRK

Procedure: LASEK

LASEK

Active Comparator: 1

PRK- Photorefractive keratectomy

Procedure: PRK

PRK

Outcome Measures

Primary Outcome Measures

Efficacy in terms of uncorrected visual acuity and post operative refraction. Safety in terms of maintenance of best spectacle corrected acuity within 2 lines of preoperative levels. [12 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Informed consent.
Normal, healthy, active duty adults age 21 years or older. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
Manifest refractive spherical equivalent of greater than -4.00 diopters (D) up to -10.00 D.
Best spectacle corrected visual acuity of 20/20 or better in both eyes.
Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination, as confirmed by clinical records.
Both eyes must fall in the same refraction group and there must be less than 1 D difference between eyes.
Soft contact lens users must have removed their lenses at least 2 weeks before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements and have 2 central keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50 D in either meridian.
Access to transportation to meet the follow-up requirements.
Available for evaluation during the 1-year follow-up period.
Consent of the subject's command to participate in the study.

Exclusion Criteria:

Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Women of childbearing age will take a urine pregnancy test before starting this study.
Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as keratoconus, iritis, uveitis, keratoconjunctivitis sicca, vernal conjunctivitis, lagophthalmos, corneal scarring, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
Any physical or mental impairment that would preclude participation in any of the examinations.
Prior refractive or ocular surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walter Reed Army Medical Center, Center For Refractive Surgery	Washington	District of Columbia	United States	20307

Sponsors and Collaborators

Walter Reed Army Medical Center
Madigan Army Medical Center
C.R.Darnall Army Medical Center
Blanchfield Army Community Hospital
Tripler Army Medical Center

Investigators

Principal Investigator: KRAIG S BOWER, MD, DIRECTOR, CENTER FOR REFRACTIVE SURGERY WALTER REED ARMY MEDICAL CENTER

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00415077

Other Study ID Numbers:

WRAMC WU# 04-23009

First Posted:

Dec 22, 2006

Last Update Posted:

Jul 16, 2010

Last Verified:

Jul 1, 2010

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Jul 16, 2010