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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048380
• Other study ID #: R1958/01/2023
• Status: Recruiting
• Phase: Phase 3
• Start date: October 2023
• Est. completion date: July 2025

Study information

• Verified date: September 2023
• Source: Singapore Eye Research Institute
• Contact: Marcus Ang
• Phone: +65 62277255
• Email: Marcus.Ang[@]Singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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%

Related Conditions & MeSH terms

• Cataract
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• 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.

Other:
• Placebo
Saline eye drops

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.	The ECD at 15 different locations of the cornea is measured with a widefield specular microscope.; This assessment will be done pre-surgery, 1 month, 3 months and 6 months post-surgery.	3 months
Secondary	To monitor for conjunctival hyperemia in participants in treatment group.	The Cornea and Contact Lens Research Unit (CCLRU) grading scale will be used as an objective assessment guideline for grading conjunctival hyperaemia.; The investigators will grade the conjunctival hyperemia 1 month, 3 months and 6 months post surgery.	6 months
Secondary	To monitor for gastrointestinal effects in participants in treatment group.	Investigators will ask participants if they experience gastrointestinal upset, abdominal pain or constipation during 1 month, 3 months and 6 months post surgery.	6 months