Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients With Corneal Blindness: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 主要终点
- To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Study Group
Patients meeting the eligibility criteria will be randomized. Those randomized to the investigational group will be treated with the investigational device.
干预措施: Investigational Keratoprosthesis Implantation (Device)
Control Group
Patients meeting the eligibility criteria will be randomized. Those randomized to the control group will receive the control device.
干预措施: Control Medical Device (Device)
结局指标
主要结局
To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation.
时间窗: 6 months postoperatively
To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation.
次要结局
- Best Corrected Visual Acuity (BCVA)(Follow-up at 1, 3, 6, and 12 months after Stage II surgery)
- Uncorrected Visual Acuity (UCVA)(Follow-up at 1, 3, 6, and 12 months after Stage II surgery)
- Blindness Resolution Rate(Follow-up at 1, 3 and 12 months after Stage II surgery)