Evaluation of Conventional Photorefractive Keratectomy (PRK) in U.S. Army Personnel, Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel

This study has been completed.
Sponsor:
Collaborator:
United States Naval Medical Center, San Diego
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00412568
First received: December 15, 2006
Last updated: March 31, 2008
Last verified: November 2007
  Purpose

The purpose of this study is to:

  1. evaluate the safety and efficacy of conventional PRK in U.S. Army personnel who have naturally occurring myopia with or without astigmatism.
  2. compare the data from this control group to study groups undergoing wavefront guided PRK.

Condition Intervention
Myopia
Procedure: Photorefractive Keratectomy (PRK)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Conventional Photorefractive Keratectomy (PRK) in U.S. Army Personnel, Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel

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

Primary Outcome Measures:
  • safety, efficacy, and refractive stability [ Time Frame: one year after procedure ]

Estimated Enrollment: 150
Study Start Date: May 2004
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Active Comparator: 1
PRK control group
Procedure: Photorefractive Keratectomy (PRK)
vision correction with PRK

  Eligibility

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

Inclusion Criteria:

  1. Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
  2. Manifest refractive spherical equivalent (MSE) of up to 6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00 D.
  3. Manifest refraction and LADARWave™ refractions must be within 1.00 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. 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; mires should be regular.
  7. Located in the greater Washington DC area for a 12-month period.
  8. Consent of the subject's command (active duty) to participate in the study.
  9. Access to transportation to meet follow-up requirements.

Exclusion Criteria:

  1. Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy.
  2. Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
  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. Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
  5. Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
  6. Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
  7. History of recurrent erosions or epithelial basement dystrophy.
  8. Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
  9. Any physical or mental impairment that would preclude participation in any of the examinations.
  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: NCT00412568

Locations
United States, District of Columbia
Walter Reed Army Medical Center, Center For Refractive Surgery
Washington, District of Columbia, United States, 20302
Sponsors and Collaborators
Walter Reed Army Medical Center
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: KRAIG S. BOWER, MD Walter Reed Army Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00412568     History of Changes
Other Study ID Numbers: WRAMC WU # 04-2335-99d, WU #2335-99 (master protocol)
Study First Received: December 15, 2006
Last Updated: March 31, 2008
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Naturally occuring myopia with or without astigmatism.

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014