Status:
COMPLETED
Evaluation of Epi-lasik in U.S. Army Personnel
Lead Sponsor:
Walter Reed Army Medical Center
Conditions:
Myopia
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Epi-Lasik in U.S. Army personnel who have naturally occurring myopia with or without astigmatism. The data from this control group w...
Eligibility Criteria
Inclusion
- Active duty US Army Soldiers eligible for care at WRAMC
- 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.
- Manifest refractive spherical equivalent (MSE) of up to 6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00 D.
- Manifest refraction and LADARWave™ refractions must be within 1.00 D.
- Best spectacle corrected visual acuity of 20/20 or better in both eyes.
- 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.
- 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.
- Subject must expect to be located in the greater Washington DC area for a 12 month period post-operatively.
- Consent of the subject's command (active duty) to participate in the study.
- Access to transportation to meet follow-up requirements
Exclusion
- 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. \[Pregnancy and breastfeeding are contraindications to refractive surgery in general, including epi-lasik, whether participating in this study or not\]
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
- 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.
- Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
- Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
- Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- History of recurrent erosions or epithelial basement dystrophy.
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment that would preclude participation in any of the examinations.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00413517
Start Date
November 1 2006
End Date
September 1 2009
Last Update
July 16 2010
Active Locations (1)
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1
Walter Reed Army Medical Center, Center for Refractive Surgery
Washington D.C., District of Columbia, United States, 20307