NCT02764814已完成不适用
In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye
Tissue Tech Inc.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Short-term efficacy in terms of corneal nerve regeneration
研究概览
简要总结
Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional treatment in patients with moderate to severe Dry Eye Disease (DED)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Subjects with moderate to severe DED (Grade 2-4 DEWS)
- •Age range: 21 years and older.
- •Both genders and all ethnic groups comparable with the local community.
- •Subjects able to understand and willing to sign a written informed consent.
- •Subjects able and willing to cooperate with investigational plan.
- •Subjects able and willing to complete postoperative follow-up.
排除标准
- •Symblepharon or lid abnormality preventing ProKera placement.
- •Ocular infection within 14 days prior to study entry.
- •Active ocular allergies.
- •Previous ocular surgery or injury within 3 months before enrollment.
- •Previous brain surgery, or Trigeminal nerve damage.
- •Other conditions that may affect corneal nerves such as diabetes, thyroid disorders.
- •Contact lens wearers.
- •Pregnancy or subject expecting to be pregnant.
- •Inability or unwillingness of subject to give written informed consent.
- •Subjects with known intolerance to PK.
- •Subjects use concomitant therapy that affects tear functions or ocular surface integrity.
- •Subjects currently engaged in another clinical trial.
结局指标
主要结局
Short-term efficacy in terms of corneal nerve regeneration
时间窗: Change from Baseline to 1 month
Assessed by corneal topography
Short-term efficacy in terms of ocular surface integrity
时间窗: Change from Baseline to 1 month
Assessed by in vivo confocal microscopy
Short-term efficacy in terms of corneal sensitivity
时间窗: Change from Baseline to 1 month
Short-term efficacy in terms of ocular clinical symptoms
时间窗: Change from Baseline to 1 month
Assessed by SPEED questionnaire, pain score, and dry eye workshop grading
次要结局
- Long-term efficacy in terms of corneal nerve regeneration(Change from Baseline to 3 month)
- Long-term efficacy in terms of ocular surface integrity(Change from Baseline to 3 month)
- Long-term efficacy in terms of corneal sensitivity(Change from Baseline to 3 month)
- Long-term efficacy in terms of ocular clinical symptoms(Change from Baseline to 3 month)
研究者
研究点 (2)
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