Clinical trial NCT06048380: The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
Official title: The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Fuchs' Endothelial Dystrophy
Cataract
Keywords: Ripasudil
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%

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%

Primary outcomes:
measure: Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
timeFrame: 3 months
Secondary outcomes:
measure: To monitor for conjunctival hyperemia in participants in treatment group.
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore Eye Research Institute
name: Marcus Ang
role: PRINCIPAL_INVESTIGATOR
References: