Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients With Corneal Blindness: A Clinical Study

Обзор

This is a prospective, multicenter, randomized controlled (1:1) non-inferiority clinical trial. A total of 54 subjects are scheduled to be enrolled at no fewer than 2 study sites in China. After providing written informed consent, all subjects will undergo screening assessments. Those who fully meet all inclusion criteria and satisfy none of the exclusion criteria will be enrolled in this clinical trial.

Вмешательства

• Устройство Investigational Keratoprosthesis Implantation
  Screen eligible patients who meet all inclusion criteria, complete randomization, and implant the investigational device per the randomization assignment. All surgical procedures must be performed in strict accordance with the clinical trial protocol and the product's instructions for use. Postoperative follow-up visits and relevant examinations shall be completed in full compliance with protocol requirements.
• Устройство Control Medical Device
  This study adopts a randomized controlled design. Following provision of written informed consent, participants will complete the screening assessments. Eligible subjects meeting all inclusion criteria and satisfying none of the exclusion criteria will be randomized in a 1:1 ratio to either the investigational group or the control group.

Первичные конечные точки

• To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation. [Срок оценки: 6 months postoperatively]

Вторичные конечные точки (3)

• Best Corrected Visual Acuity (BCVA) [Срок оценки: Follow-up at 1, 3, 6, and 12 months after Stage II surgery]
• Uncorrected Visual Acuity (UCVA) [Срок оценки: Follow-up at 1, 3, 6, and 12 months after Stage II surgery]
• Blindness Resolution Rate [Срок оценки: Follow-up at 1, 3 and 12 months after Stage II surgery]

Критерии участия

Критерии включения

• Age 18 to 80 years (inclusive), gender unrestricted;
• Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity < 0.05 in both eyes;
• Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation;
• Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery;
• Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP < 21 mmHg);
• Normal structure and function of the retina and optic nerve, with preserved visual potential;
• Willing to participate in this study and have signed the written informed consent form.

Критерии исключения

• Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery.
• Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery.
• Patients with unhealed wound following allogeneic penetrating keratoplasty.
• Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin.
• Patients with severely impaired retinal or optic nerve function with no potential for visual improvement.
• Patients with a history of malignant tumor in or around the eye, judged ineligible by the investigator.
• Patients with intolerance to local anesthetics, mydriatics, or device components, judged ineligible by the investigator.
• Patients with severe diseases of major organs including heart, liver, and kidney, judged ineligible by the investigator.
• Patients with severe coagulation disorders, judged ineligible by the investigator.
• Patients with absolute glaucoma, judged ineligible by the investigator.
• Patients with severe systemic diseases and a life expectancy of < 2 years.
• Pregnant or lactating females.
• Patients who do not understand the risks of keratoprosthesis surgery, cannot comply with regular follow-up, or fail to administer medication as required.
• Other patients considered ineligible for this clinical trial by the investigator.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07526389 · VSE-KP-001 · Company

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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