Evaluation of Epi-lasik in U.S. Army Personnel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00413517
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : July 16, 2010
Information provided by:
Walter Reed Army Medical Center

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 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 or disease Intervention/treatment Phase
Myopia Procedure: Epi-Lasik Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Epi-lasik in U.S. Army Personnel
Study Start Date : November 2006
Actual Study Completion Date : September 2009

Intervention Details:
    Procedure: Epi-Lasik
    A vision correcting surgery

Primary Outcome Measures :
  1. Safety and efficacy of Epi-LASIK [ Time Frame: 12 months after procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Active duty US Army Soldiers eligible for care at WRAMC
  2. 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.
  3. Manifest refractive spherical equivalent (MSE) of up to 6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00 D.
  4. Manifest refraction and LADARWave™ refractions must be within 1.00 D.
  5. Best spectacle corrected visual acuity of 20/20 or better in both eyes.
  6. 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.
  7. 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.
  8. Subject must expect to be located in the greater Washington DC area for a 12 month period post-operatively.
  9. Consent of the subject's command (active duty) to participate in the study.
  10. 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. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including epi-lasik, whether participating in this study or not]
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00413517

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
Principal Investigator: KRAIG S. BOWER, MD Walter Reed Army Medical Center Identifier: NCT00413517     History of Changes
Other Study ID Numbers: WRAMC WU # 06-23020
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010

Keywords provided by Walter Reed Army Medical Center:
Naturally occurring myopia with or without astigmatism

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases