NCT01592643已完成不适用
Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.
研究概览
简要总结
The purpose of this research is to determine if an investigational thin shield over the cornea can safely and effectively reduce or eliminate pain following Post Photorefractive Keratectomy (PRK).
The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.
详细描述
See above
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age 18 and older with healthy eyes.
- •Nearsightedness between -0.50 diopters and -11.00 diopters with or without astigmatism of up to 3.50 diopters.
排除标准
- •Subjects under the age of
- •Patients with excessively thin corneas.
- •Patients with topographic evidence of keratoconus.
- •Patients with ectactic eye disorders.
- •Patients with autoimmune diseases.
- •Patients who are pregnant or nursing.
- •Any other anterior segment abnormality other than that associated with PRK
- •Any abnormalities associated with the eye lids
- •Uncontrolled blepharitis or dry eye
- •Prior laser treatment of the retina
- •Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK
- •Diagnosis of glaucoma
- •Active diabetic retinopathy
- •Clinically significant inflammation or infection within six (6) months prior to study
- •Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator
- •Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material
- •Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material
- •A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
- •Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
研究组 & 干预措施
Eye shield
Experimental
Participants receive eye shield during PRK surgery
干预措施: Eye Shield (Device)
结局指标
主要结局
Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.
时间窗: Day 30
次要结局
- Mean Change in Uncorrected Visual Acuity(Six months)
研究者
Edward E. Manche
Professor of Ophthalmology
Stanford University
研究点 (1)
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