Optimizing the Ocular Surface Prior to Cataract Surgery

Tissue Tech Inc.1 个研究点分布在 1 个国家目标入组 20 人2016年3月

适应症Corneal Dystrophy, Epithelial Basement Membrane

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Corneal Dystrophy, Epithelial Basement Membrane
发起方: Tissue Tech Inc.
入组人数: 20
试验地点: 1
主要终点: Change in Intraocular Lens Calculation
状态: 已完成
最后更新: 7年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.

注册库

clinicaltrials.gov

开始日期

2016年3月

结束日期

2018年4月

最后更新

7年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Tissue Tech Inc.

责任方

Sponsor

入排标准

入选标准

•Subjects with significant EBMD that are contemplating cataract surgery.
•Age range: 50 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 the investigational plan.
•Subjects able and willing to complete postoperative follow-up.

排除标准

•Subjects with known intolerance to PKS or known allergy to its preservative media.
•Subjects with symblepharon or lid abnormality preventing PKS placement.
•Ocular infection within 14 days prior to study entry.
•Previous ocular surgery or injury within 3 months before enrollment.
•Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
•Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.