The Effects of Ripasudil in Patients with FED Undergoing Femtosecond Laser Assisted Cataract Surgery
The Effects of Ripasudil in Patients with Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 0.4%
- To identity which FED patients will most likely benefit from the use of ripasudil 0.4% based on pre-operative parameters
- To monitor for any adverse effects in patients assigned to ripasudil 0.4%
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Marcus Ang
- Phone Number: +65 62277255
- Email: Marcus.Ang@Singhealth.com.sg
Study Locations
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-
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Singapore, Singapore, 168751
- Recruiting
- Singapore National Eye Centre
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Contact:
- Marcus Ang
- Phone Number: +65 62277255
- Email: Marcus.Ang@Singhealth.com.sg
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Contact:
- Marcus Ang
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
- Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
- Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
- Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery.
Exclusion Criteria:
- Patients who are unable to give consent.
- An only-functioning eye in a patient who has lost visual potential in the contralateral eye.
- Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study.
- History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease.
- Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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 Names:
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Placebo Comparator: Placebo
Participants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery.
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Saline eye drops
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
Time Frame: 3 months
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The ECD at 15 different locations of the cornea is measured with a widefield specular microscope. This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery. |
3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To monitor for conjunctival hyperemia in participants in treatment group.
Time Frame: 3 months
|
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 This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery. |
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcus Ang, Singapore Eye Research Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R1958/01/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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