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

Singapore Eye Research Institute (Other)
Overall Status
Recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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%

Study Design

Study Type:
Anticipated Enrollment :
120 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
Official Title:
The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Participants in this group will be asked to instill Glanatec Ophthalmic Solution (containing Ripasadil 0.4%) 4 times a day for 3 months following cataract removal surgery.

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 Names:
  • Glanatec
  • Placebo Comparator: Placebo

    Participants in this group will be asked to instill saline solution 4 times a day for 3 months following cataract removal surgery.

    Other: Placebo
    Saline eye drops

    Outcome Measures

    Primary Outcome Measures

    1. Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo. [3 months]

      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.

    Secondary Outcome Measures

    1. To monitor for conjunctival hyperemia in participants in treatment group. [6 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 1 month, 3 months and 6 months post surgery.

    2. To monitor for gastrointestinal effects in participants in treatment group. [6 months]

      Investigators will ask participants if they experience gastrointestinal upset, abdominal pain or constipation during 1 month, 3 months and 6 months post surgery.

    Eligibility Criteria


    Ages Eligible for Study:
    50 Years to 100 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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%

    Contacts and Locations


    Site City State Country Postal Code
    1 Singapore National Eye Centre Singapore Singapore 168751

    Sponsors and Collaborators

    • Singapore Eye Research Institute


    • Principal Investigator: Marcus Ang, Singapore Eye Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Marcus Ang Han Nian, A/Professor, Singapore Eye Research Institute Identifier:
    Other Study ID Numbers:
    • R1958/01/2023
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    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.:
    Keywords provided by Marcus Ang Han Nian, A/Professor, Singapore Eye Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2023