Evaluation of Epi-lasik in U.S. Army Personnel
This study has been completed.
Sponsor:
Walter Reed Army Medical Center
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00413517
First received: December 18, 2006
Last updated: July 15, 2010
Last verified: July 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 will be collected in such a way as to be comparable to data sets from study groups undergoing wavefront guided PRK, conventional PRK, and related laser refractive surgery procedures.
| Condition | Intervention |
|---|---|
|
Myopia |
Procedure: Epi-Lasik |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Epi-lasik in U.S. Army Personnel |
Further study details as provided by Walter Reed Army Medical Center:
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413517
Locations
| United States, District of Columbia | |
| Walter Reed Army Medical Center, Center for Refractive Surgery | |
| Washington, District of Columbia, United States, 20307 | |
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
| Principal Investigator: | KRAIG S. BOWER, MD | Walter Reed Army Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00413517 History of Changes |
| Other Study ID Numbers: | WRAMC WU # 06-23020 |
| Study First Received: | December 18, 2006 |
| Last Updated: | July 15, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Walter Reed Army Medical Center:
|
Naturally occurring myopia with or without astigmatism |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013