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

December 19, 2006
March 31, 2008
August 2001
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safety and efficacy of PRK [ Time Frame: 12 months after surgery ]
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Complete list of historical versions of study NCT00413673 on ClinicalTrials.gov Archive Site
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Initial Evaluation of Photorefractive Keratectomy in U.S. Army Personnel
Initial Evaluation of Photorefractive Keratectomy in U.S. Army Personnel

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.

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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myopia
Procedure: PRK
PRK
Experimental: 1
PRK
Intervention: Procedure: PRK
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2008
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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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00413673
WRAMC WU # 2335-99
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Walter Reed Army Medical Center
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Principal Investigator: KRAIG S. BOWER, MD Walter Reed Army Medical Center
Walter Reed Army Medical Center
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP