Initial Evaluation of Photorefractive Keratectomy in U.S. Army Personnel

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00413673
First received: December 19, 2006
Last updated: March 31, 2008
Last verified: November 2007
  Purpose

The objective of this study is to conduct a prospective clinical trial to evaluate the safety and efficacy fo the VISX Excimer Laser system for the treatment of naturally occurring low to moderate myopia, with or without low levels of astigmatism, in U.S. Army personnel.


Condition Intervention
Myopia
Procedure: PRK

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Initial Evaluation of Photorefractive Keratectomy in U.S. Army Personnel

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

Primary Outcome Measures:
  • safety and efficacy of PRK [ Time Frame: 12 months after surgery ]

Estimated Enrollment: 100
Study Start Date: August 2001
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Experimental: 1
PRK
Procedure: PRK
PRK

  Eligibility

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

Inclusion Criteria:

  • Informed consent.
  • Normal, healthy active adults with access to medical care at Walter Reed Health Care System.
  • Age 21 years or older.
  • Spherical equivalent of the manifest refractive error between -1.0 to -6.0 diopters (D), inclusive, with no more than 3.0D of cylinder. The absolute value of the cylinder (expressed in minus cylinder) will be limited such that the short axis of the elliptical ablation will be no smaller than 4.9mm. The following specifies the maximum cylinder for a given spherical component of the manifest refraction:

Spherical component / Maximum cylinder

  • 1.0D / -0.5D
  • 2.0D / -1.0D
  • 3.0D / -1.5D
  • 4.0D / -2.0D
  • 5.0D / -2.5D
  • 6.0D / -3.0D
  • Corrected vision of at least 20/20
  • Soft contact lens users must havE removed their lenses at least two weeks prior to baseline measurements.
  • Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four weeks prior to baseline measurements. At least two weekly manifest refractions and keratometry measurements will be required in this interval. The last two measurements must not vary by more than 0.50D in any meridian.
  • Patients undergoing orthokeratology must have their lenses removed at least 6 months prior to the baseline examination. At least two monthly manifest refractions and keratometry measurements taken after the third month out of lenses must not vary by more than 0.50D in any meridian.
  • Refractive stability must be documented by previous refractions. Spherical and cylindrical portion of the manifest refraction must not have varied by more than 0.50D over the previous 12 months.
  • Exhibits strong motivation for keeping the follow-up visits.
  • Available for evaluation at Walter Reed during the two-year follow-up period.
  • Service members must have their command approval to participate in the study.
  • Access to transportation to meet follow-up requirements.

Exclusion Criteria:

  • Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
  • Either one or both eyes suffering from chronic dryness.
  • Taking any systemic medications that may affect wound healing such as corticosteroids or antimetabolites.
  • Patient corneal neovascularization within one mm of the ablation zone.
  • History of any previous eye surgery, including previous refractive surgery.
  • Best corrected visual acuity of less than 20/20.
  • Progressive myopia or keratoconus.
  • Any systemic disease that may affect wound healing, such as connective tissue disorders (rheumatoid arthritis, systemic lupus erythematosus, etc.), diabetes, or severe atopic disease.
  • Any physical or mental impairment that would preclude participation in any of the examinations.
  • For contact lens users there must be no evidence of contact lens corneal warpage on computerized topography.
  • Currently on flight status or projected to be on flight status within ten years.
  • Pregnant or breast-feeding an infant. Women of childbearing age must take a urine blood pregnancy test before starting this study
  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: NCT00413673

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
Investigators
Principal Investigator: KRAIG S. BOWER, MD Walter Reed Army Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00413673     History of Changes
Other Study ID Numbers: WRAMC WU # 2335-99
Study First Received: December 19, 2006
Last Updated: March 31, 2008
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Naturally occurring low to moderate myopia, with or without low levels of astigmatism in U.S. Army personnel

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 11, 2014