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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form, and are willing and able to sign a written willing to sign a consent form 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. Who Should NOT Join This Trial: 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% Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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%

Treatments Being Tested

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 (1)

Singapore National Eye Centre
Singapore, Singapore, Singapore