Clinical trial NCT00412295: Evaluation of Alcon Ladarvision Wavefront-Guided PRK
Official title: Evaluation of Alcon Ladarvision Wavefront-Guided PRK
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myopia
Keywords: Naturally occuring myopia with or without astigmatism.
Wavefront errors
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
Collaborators: name: Walter Reed Army Medical Center
First posted: 2006-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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 wavefront guided PRK


Eligibility 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.

Primary outcomes:
measure: Corrected distance visual acuity (CDVA)
timeFrame: 12 months
measure: Uncorrected distance visual acuity (UDVA)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center
state: California
city: Washington
country: United States
facility: Walter Reed Army Medical Center, Center For Refractive Surgery
state: District of Columbia
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: STEVEN SCHALLHORN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed Army Medical Center
name: KRAIG S BOWER, MD
role: PRINCIPAL_INVESTIGATOR
References: