NCT00741624已完成2 期
Mitigating Pain Following Refractive Surgery
FORSIGHT Vision31 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain
详细描述
Assessed for pain at 1, 2 and 4 hours and 1, 3 and 5 days. Comparison to non study eye will be performed.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent bilateral PRK for myopic correction.
- •Patient complains of significant pain.
- •Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits
排除标准
- •Any other anterior segment abnormality other than that associated with PRK.
- •Any abnormalities associated with the eye lids.
- •Prior laser treatment of the retina.
- •Any ophthalmic surgery performed within three (3) months prior to study excluding PRK.
- •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 device.
- •Specifically known intolerance or hypersensitivity to contact lenses.
- •A medical condition, serious intercurrent 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.
结局指标
主要结局
Pain relief
时间窗: 1 week
次要结局
未报告次要终点
研究者
研究点 (1)
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