The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery

NCT ID: NCT06048380

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-07-31

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 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.

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 group.

The investigators hypothesize that the ROCK inhibitor ripasudil 0.4% helps maintain corneal endothelial functional integrity and reduce cell loss after cataract surgery in patients with FED.

To test the hypothesis, the investigators plan to conduct a randomized clinical trial which aims to:

1. Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 0.4%

2. To identity which FED patients will most likely benefit from the use of ripasudil 0.4% based on pre-operative parameters

3. To monitor for any adverse effects in patients assigned to ripasudil 0.4%

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ripasudil

Intervention Type: DRUG

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.

Placebo

Participants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline eye drops

Interventions

Ripasudil

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.

Intervention Type: DRUG

Placebo

Saline eye drops

Intervention Type: OTHER

Other Intervention Names

Glanatec

Eligibility 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%

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore Eye Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Marcus Ang Han Nian

A/Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcus Ang

Role: PRINCIPAL_INVESTIGATOR

Singapore Eye Research Institute

Locations

Singapore National Eye Centre

Singapore, Singapore, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Marcus Ang

Role: CONTACT

Marcus.Ang@Singhealth.com.sg

+65 62277255

Facility Contacts

Marcus Ang

Role: primary

Marcus.Ang@Singhealth.com.sg

+65 62277255

Other Identifiers

R1958/01/2023

Identifier Type: -

Identifier Source: org_study_id