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
Singapore Eye Research Institute
120 participants
Mar 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria5
- 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%
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Interventions
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.
Saline eye drops
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06048380