Status:
RECRUITING
The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
Lead Sponsor:
Singapore Eye Research Institute
Conditions:
Fuchs' Endothelial Dystrophy
Cataract
Eligibility:
All Genders
50-100 years
Phase:
PHASE3
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06048380
Start Date
March 1 2025
End Date
July 1 2025
Last Update
January 29 2025
Active Locations (1)
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1
Singapore National Eye Centre
Singapore, Singapore, Singapore, 168751