Singapore National Eye Centre
Singapore, 168751
Location status: Recruiting
NCT Number: NCT06048380
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.
Interested in participating?
Request Info50 year–100 year
All sexes
Interventional
Phase 3
Singapore, 168751
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Glanatec
Saline eye drops
Time frame: 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.
Time frame: 3 months
The Cornea and Contact Lens Research Unit (CCLRU) grading scale will be used as an objective assessment guideline for grading conjunctival hyperaemia.
The investigators will grade the conjunctival hyperemia This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
Contact information is provided by the study sponsor or research team.
Singapore Eye Research Institute
Other
The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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