NCT00412295撤回不适用
Evaluation of Alcon Ladarvision Wavefront-Guided PRK
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Uncorrected distance visual acuity (UDVA)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Uncorrected distance visual acuity (UDVA)
时间窗: 12 months
UDVA (logMAR unit and/or snellen equivalent) will be measured to determine effectiveness of wavefront guided PRK.
Corrected distance visual acuity (CDVA)
时间窗: 12 months
CDVA (logMAR unit and/or snellen equivalent) will be measured to determine safety of wavefront guided PRK.
次要结局
未报告次要终点
研究者
Samantha B. Rodgers, MD
PRS Account holder
Walter Reed Army Medical Center
研究点 (4)
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