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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Singapore
Singapore National Eye Centre
RECRUITING
Singapore
Contact Information
Primary
Marcus Ang
Marcus.Ang@Singhealth.com.sg
+65 62277255
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2025-07
Participants
Target number of participants: 120
Treatments
Experimental: 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.
Placebo_comparator: Placebo
Participants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery.
Sponsors
Leads: Singapore Eye Research Institute

This content was sourced from clinicaltrials.gov

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