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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Procedure: PRK

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center, Center For Refractive Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; PRK	Procedure: PRK; PRK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
safety and efficacy of PRK	12 months after surgery

Collaborators and Investigators

• Sponsor: Walter Reed Army Medical Center
• Investigators: Principal Investigator: KRAIG S. BOWER, MD, Walter Reed Army Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Study Completion: March 1, 2008

Study Registration Dates

• First Submitted: December 19, 2006
• First Submitted That Met QC Criteria: December 19, 2006
• First Posted (Estimate): December 20, 2006

Study Record Updates

• Last Update Posted (Estimate): April 1, 2008
• Last Update Submitted That Met QC Criteria: March 31, 2008
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Naturally occurring low to moderate myopia, with or without low levels of astigmatism in U.S. Army personnel
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: WRAMC WU # 2335-99