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CompletedNCT00412568Updated Apr 1, 2008

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

An interventional study of Photorefractive Keratectomy (PRK) in Myopia, sponsored by Walter Reed Army Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-01.

Sponsored by Walter Reed Army Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Myopia

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Keywords

  • Naturally occuring myopia with or without astigmatism.
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Walter Reed Army Medical Center is the lead sponsor of 45 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    1

    PRK control group

    Procedure: Photorefractive Keratectomy (PRK)

Interventions

  • ProcedurePhotorefractive Keratectomy (PRK)

    vision correction with PRK

06

What researchers measure

Primary outcomes

  1. safety, efficacy, and refractive stability

    Time frame: one year after procedure

07

Study locations

1 site
  • Walter Reed Army Medical Center, Center For Refractive Surgery
    Washington, District of Columbia 20302, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00412568
Lead sponsor
Walter Reed Army Medical Center
Collaborators
United States Naval Medical Center, San Diego
First posted
Dec 18, 2006
Start date
May 2004
Completion
Mar 2008
Last update
Apr 1, 2008

Study contacts

KRAIG S. BOWER, MD
principal investigator · Walter Reed Army Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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