Effects of Ripasudil on Patients with Fuchs' Endothelial Dystrophy Undergoing Cataract Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.