The Effects of Ripasudil in Patients with Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
研究概览
简要总结
The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery. The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study.
详细描述
Patients with Fuch's Corneal Endothelial Dystrophy and undergoing femtosecond laser-assisted cataract surgery will be recruited for this study. They will be randomly assigned into treatment or placebo group.
The investigators hypothesize that the ROCK inhibitor ripasudil 0.4% helps maintain corneal endothelial functional integrity and reduce cell loss after cataract surgery in patients with FED.
To test the hypothesis, the investigators plan to conduct a randomized clinical trial which aims to:
- Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 0.4%
- To identity which FED patients will most likely benefit from the use of ripasudil 0.4% based on pre-operative parameters
- To monitor for any adverse effects in patients assigned to ripasudil 0.4%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with FED who will be listed for cataract surgery as part of standard clinical practice (A cataract will be defined as clouding of the lens that interferes with normal vision).
- •Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
- •Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
- •Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery.
排除标准
- •Patients who are unable to give consent.
- •An only-functioning eye in a patient who has lost visual potential in the contralateral eye.
- •Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study.
- •History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease.
- •Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%
研究组 & 干预措施
Treatment
Participants in this group will be asked to instill Glanatec Ophthalmic Solution (containing Ripasadil 0.4%) 4 times a day for 1 month following cataract removal surgery.
干预措施: Ripasudil (Drug)
Placebo
Participants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery.
干预措施: Placebo (Other)
结局指标
主要结局
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
时间窗: 3 months
The ECD at 15 different locations of the cornea is measured with a widefield specular microscope. This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
次要结局
- To monitor for conjunctival hyperemia in participants in treatment group.(3 months)
研究者
Marcus Ang Han Nian
A/Professor
Singapore Eye Research Institute