Status:
WITHDRAWN
Evaluation of Alcon Ladarvision Wavefront-Guided PRK
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: 1. determine the safety of wavefront guided PRK 2. evaluate the efficacy of wavefront guided PRK 3. evaluate the differences in visual quality after treatment of wave...
Eligibility Criteria
Inclusion
- Subjects will be recruited from those active duty soldiers that have requested refractive surgery. Subjects must be eligible for medical 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 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.
- At least five images must be capturesd in both eyes (dilated) with a pupil size of at least 7mm.
- Manifest refraction and LADARWave™ refractions must be within 1.00 D and the CustomCornea® software must allow for treatment with a 6.5mm minor axis and 9mm ablation zone.
- 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, sa 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 adn have 2 central Keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50D in either meridian; mires should be regular.
- Located it the greater Washington DC Area for a 12-month period.
- Exhibits strong motivation for attending the follow-up visits.
- 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.
- Concurrent topical or systemic medications that may impair healing, including corticosteriods, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
- Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular 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 22mm Hg at baseline.
- Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- History of recurrent erosions or epithelial baewsment 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 :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00412295
Last Update
July 23 2025
Active Locations (2)
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1
Naval Medical Center
San Diego, California, United States, 92134
2
Walter Reed Army Medical Center, Center For Refractive Surgery
Washington D.C., District of Columbia, United States, 20307