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NCT Number: NCT06048380

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

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.

Recruiting

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Key information

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Singapore National Eye Centre

Singapore, 168751

Location status: Recruiting

Location contact

Marcus Ang

CONTACT

[email protected]

+65 62277255

Marcus Ang

PRINCIPAL_INVESTIGATOR

About 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:

  • 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%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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.

Other names: Glanatec

Placebo

Other

Saline eye drops

Primary outcomes

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

    Time frame: 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, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcus Ang

CONTACT

[email protected]

+65 62277255

Sponsors and collaborators

Lead sponsor

Singapore Eye Research Institute

Other

Registry information

Official study title

The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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