Evaluation of Alcon Ladarvision Wavefront-Guided PRK
This study has been completed.
Sponsor:
United States Naval Medical Center, San Diego
Collaborator:
Walter Reed Army Medical Center
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00412295
First received: December 15, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
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Purpose
The purpose of this study is to:
- determine the safety of wavefront guided PRK
- evaluate the efficacy of wavefront guided PRK
- evaluate the differences in visual quality after treatment of wavefront guided PRK
| Condition | Intervention |
|---|---|
|
Myopia |
Procedure: Wavefront guided PRK |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Evaluation of Alcon Ladarvision Wavefront-Guided PRK |
Resource links provided by NLM:
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:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412295
Locations
| United States, California | |
| Naval Medical Center | |
| San Diego, California, United States, 92134 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center, Center For Refractive Surgery | |
| Washington, District of Columbia, United States, 20307 | |
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Walter Reed Army Medical Center
Investigators
| Principal Investigator: | STEVEN SCHALLHORN, MD | United States Naval Medical Center, San Diego |
| Principal Investigator: | KRAIG S BOWER, MD | Walter Reed Army Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00412295 History of Changes |
| Other Study ID Numbers: | WRAMC WU#04-23006 |
| Study First Received: | December 15, 2006 |
| Last Updated: | December 15, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Walter Reed Army Medical Center:
|
Naturally occuring myopia with or without astigmatism. Wavefront errors |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013