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

This study has been terminated.
(Change in excimer laser systems prior to completion of study)
Sponsor:
Collaborators:
Madigan Army Medical Center
C.R.Darnall Army Medical Center
Blanchfield Army Community Hospital
Tripler Army Medical Center
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00415077
First received: December 21, 2006
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

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 Intervention
MODERATE AND HIGH MYOPIA
Procedure: PRK
Procedure: MMC PRK
Procedure: LASEK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

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. [ Time Frame: 12 months after surgery ]

Estimated Enrollment: 960
Study Start Date: June 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Informed consent.
  2. 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.
  3. Manifest refractive spherical equivalent of greater than -4.00 diopters (D) up to -10.00 D.
  4. Best spectacle corrected visual acuity of 20/20 or better in both eyes.
  5. 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.
  6. Both eyes must fall in the same refraction group and there must be less than 1 D difference between eyes.
  7. 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.
  8. Access to transportation to meet the follow-up requirements.
  9. Available for evaluation during the 1-year follow-up period.
  10. Consent of the subject's command to participate in the study.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
  5. Any physical or mental impairment that would preclude participation in any of the examinations.
  6. Prior refractive or ocular surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415077

Locations
United States, District of Columbia
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00415077     History of Changes
Other Study ID Numbers: WRAMC WU# 04-23009
Study First Received: December 21, 2006
Last Updated: July 15, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on July 23, 2014