evaluation of alcon ladarvision wavefront-guided prk

Conditions: Myopia

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.

Keywords: naturally occuring myopia with or without astigmatism. wavefront errors