NCT04054817已完成不适用
A Multicenter, Open-label, Single-arm Study Assess the Collagen Ophthalmic Matrix for Anterior Lamellar Keratoplasty.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.
研究概览
简要总结
The goal of this clinical trial is to investigate the safety and clinical performance of ABCcolla Collagen Ophthalmic Matrix used for anterior lamellar keratoplasty in patients suffering from corneal ulcer.
Participants will undergo keratoplasty using the investigational product and be followed up for 24-week observation (total of 10 times).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.
时间窗: After the surgery, patients will be examined for follow-up observation for 24 weeks.
Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate
次要结局
- The extent of graft vascularization(24-week follow-up visit. Totoa 9 times.)
- The extend of corneal edema(24-week follow-up visit. Totoa 9 times.)
- Best corrected vision acuity(24-week follow-up visit. Totoa 9 times.)
- The extent of graft transparency(24-week follow-up visit. Totoa 9 times.)
- Infection recurrence(24-week follow-up visit. Totoa 9 times.)
- Light sensitivity(24-week follow-up visit. Totoa 9 times.)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
不适用
PROACTIVE-HF IDE Trial Heart Failure NYHA Class IIIHeart Failure NYHA Class IIINCT04089059Endotronix, Inc.738
招募中
不适用
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical TrialInfrapopliteal LesionsCritical Limb IschemiaNCT05971394Biotyx Medical (Shenzhen) Co., Ltd.100
招募中
1 期
A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic CancerPancreatic CancerNCT05911217CARsgen Therapeutics Co., Ltd.20
尚未招募
1 期
Surufatinib Combined With Tislelizumab in the Second-line and Further Treatment of Triple-negative Breast CancerMetastatic Triple-negative Breast CancerNCT05746728Huihua Xiong45
进行中（未招募）
不适用
ULTRA LONG: BioFreedom UltraHigh Bleeding Risk PatientsCoronary Artery DiseaseNCT05643430Biosensors Europe SA86