NCT00915759已完成不适用
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Days to Complete Re-epithelialization
研究概览
简要总结
The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active duty US Army Soldiers eligible for care at WRAMC.
- •Male or female, of any race, and at least 21 years old at the time of the preoperative examination, and have signed and informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- •Subject must expect to be located in the greater Washington, District of Columbia area for a 12 month period post-operatively.
- •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
- •Any reason to be excluded for PRK.
- •Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be give a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
- •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.
- •Anterior basement membrane dystrophy.
- •History of recurrent epithelial erosion.
- •Significant dry eye (symptomatic with Schirmer test < 5 mm at 5 minutes).
- •Other corneal epithelial disorder or healing abnormality.
- •Patients with unusually tight eyelids close to the eyeball making it difficult and/ or painful to insert anything (e.g., ProKera) between the eyelid and globe.
结局指标
主要结局
Number of Days to Complete Re-epithelialization
时间窗: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy
次要结局
- Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)(Day 1)
- Number of Eyes With Complications/Adverse Events(up to one year post-operatively)
- Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively(one year post-operatively)
- Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively(one year post-operatively)
- Number of Eyes With Clinically Significant Corneal Haze(one year postoperatively)
- Tear Total Protein Levels(1 month post-operatively)
研究者
研究点 (2)
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