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

Launched by WALTER REED ARMY MEDICAL CENTER · Dec 15, 2006

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.