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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Placebo | Placebo Comparator | Participants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ripasudil | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcus Ang | Contact | +65 62277255 | Marcus.Ang@Singhealth.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Marcus Ang | Singapore Eye Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Centre | Recruiting | Singapore | Singapore | 168751 | Singapore |
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| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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| ID | Term |
|---|---|
| C584679 | K-115 |
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|
|
| Placebo | Other | Saline eye drops |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007905 | Lens Diseases |