NCT06048380

The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery

The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Singapore Eye Research Institute · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 0.4% 2. To identity which FED patients will most likely benefit from the use of ripasudil 0.4% based on pre-operative parameters 3. To monitor for any adverse effects in patients assigned to ripasudil 0.4%

Conditions

• Fuchs' Endothelial Dystrophy
• Cataract

Interventions

Type	Name	Description
DRUG	Ripasudil	Glanatec Ophthalmic Solution 0.4% W/V with ripasudil hydrochloride hydrate as active ingredient is currently being used by patients with ocular hypertension or open-angle glaucoma. Inhibition of Rho kinase to facilitate aqueous outflow from the conventional outflow pathway via the trabecular meshwork and Schlemm's canal has been suggested as the IOP-lowering mechanism of action by ripasudil.
OTHER	Placebo	Saline eye drops

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-09-21
• Last updated: 2025-01-29

Locations

1 site across 1 country: Singapore