Effects of Ripasudil on Patients with Fuchs' Endothelial Dystrophy Undergoing Cataract Surgery
The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
This study is testing if a new eye drop called ripasudil can help people with Fuchs' Endothelial Dystrophy have better results after cataract surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | Singapore Eye Research Institute Academic / other |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT06048380 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of ripasudil, an ophthalmic solution, on patients with Fuchs' Endothelial Dystrophy (FED) who are undergoing femtosecond laser-assisted cataract surgery. Participants will be randomly assigned to receive either ripasudil or a placebo, allowing researchers to evaluate the clinical outcomes and identify which patients benefit most from the treatment. The study also aims to monitor any adverse effects associated with ripasudil administration. By analyzing pre-operative parameters, the trial seeks to enhance understanding of patient characteristics that predict treatment success.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 50 years old diagnosed with Fuchs' Endothelial Dystrophy who are scheduled for cataract surgery.
Not a fit: Patients with only one functioning eye or those with other significant eye diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve corneal endothelial function and reduce cell loss after cataract surgery in patients with FED.
How similar studies have performed: While the use of ROCK inhibitors like ripasudil is promising, this specific application in FED patients undergoing cataract surgery is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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). 2. Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied. 3. Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures. 4. Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery. Exclusion Criteria: 1. Patients who are unable to give consent. 2. An only-functioning eye in a patient who has lost visual potential in the contralateral eye. 3. Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study. 4. History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease. 5. Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%
Where this trial is running
Singapore, Singapore
- Singapore National Eye Centre — Singapore, Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Marcus Ang — Singapore Eye Research Institute
- Study coordinator: Marcus Ang
- Email: Marcus.Ang@Singhealth.com.sg
- Phone: +65 62277255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.