Clinical Assessment of Auro KPro
试验速览
- 阶段
- 4 期
- 发起方
- Aurolab
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes.
详细描述
The keratoprosthesis, also know as an artificial cornea plays a significant role in combating corneal blindness in patients who are no longer candidates for penetrating keratoplasty.The global incidence of corneal blindness is estimated to be 6-8 million. In India there are approximately 6.8 million cases of unilateral corneal blindness and 1.3 million people with bilateral corneal pathology.
Eligible subjects after getting informed consent will be included in this study. All the subjects will have pre-operative evaluation which includes history, visual acuity, Intraocular pressure (IOP), evaluation of tear film and ultrasound A and B scan. Ocular inflammation will be controlled prior to surgery. Keratoplasty will be performed with keratoprosthesis under local anesthesia. Patients will be followed up at regular interval to assess the outcome variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 20 years
- •Willing to participate and review on schedule
- •Multiple failed grafts with poor prognosis for regrafting
- •Adequate tear film and lid function
- •Projection of light in all quadrants
- •Bilateral blind
排除标准
- •Reasonable chance of success with keratoplasty
- •Autoimmune disease such as Stevens Johnson Syndrome, Pemphigoid
- •End stage glaucoma
- •Retinal detachment
结局指标
主要结局
Visual Acuity
时间窗: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month
次要结局
- Retention of the device(1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month)