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

Официальное название

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

Обзор

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.

Подробное описание

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%

Вмешательства

• Препарат 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.
• Другое Placebo
  Saline eye drops

Первичные конечные точки

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

Вторичные конечные точки (1)

• To monitor for conjunctival hyperemia in participants in treatment group. [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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%

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Сингапур · 1 центр

• Singapore National Eye Centre — Singapore

Идентификаторы

NCT: NCT06048380 · R1958/01/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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