A Prospective, Randomized, Open Label Clinical Trial to Evaluate the Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea Compared to Human Cornea in Patients Requiring Anterior Lamellar Keratoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Safety (Degree of eye inflammation)
研究概览
简要总结
In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating networks of recombinant human type III collagen and synthetic phospholipid - phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection, trauma or keratoconus. Control group will consist of patients with the same condition who will undergo corneal transplantation - current standard of care.
详细描述
Recently developed and passed extensive pre-clinical testing collagen-phosphorylcholine(RHCIII-MPC) corneal substitute will be implanted in patient's corneas with corneal scar (leukoma) developed after infection, trauma or keratoconus using anterior lamellar keratoplasty technique, i.e. once patient's diseased anterior part of cornea is removed, either manually or with assistance of femtosecond laser, it will be substituted with proposed transparent implant. Control patients with same condition will be grafted with human donor cornea using the same surgical technique.
The investigators will test the safety and the effectiveness of developed biosynthetic corneas. Overall 20 patients are planned to recruit. They will be randomized in two groups - 10 patients will undergo RHCIII-MPC cornea implantation, another 10 will be impanted with human donor cornea. The patients will be follow-uped for 12 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must sign and be given a copy of the written Informed Consent form.
- •Subjects with best corrected distance visual acuity +1.0 LogMAR or worse as a result of corneal scar due to infection, injury or keratoconus in the operative eye.
- •Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.
排除标准
- •Subjects with severe or life-threatening systemic disease.
- •Subjects with uncontrolled hypertension.
- •Subjects with uncontrolled diabetes or insulin-dependent diabetes.
- •Subjects with glaucoma in either eye.
- •Subjects with marked microphthalmos or aniridia in either eye.
- •Subjects with any other serious ocular pathology, serious ocular complications at the time of surgery underlying serious medical conditions, based on the investigator's medical judgment.
- •Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.
研究组 & 干预措施
RHCIII-MPC cornea
Patients of this arm will undergo RHCIII-MPC bioengineered cornea transplantation using anterior lamellar keratoplasty technique
干预措施: RHCIII-MPC cornea (Device)
Donor cornea
Patients of this arm will undergo human donor cornea transplantation using anterior lamellar keratoplasty technique
干预措施: Donor cornea (Device)
结局指标
主要结局
Safety (Degree of eye inflammation)
时间窗: 12 months
Degree of eye inflammation based on conjunctival injection, perifocal corneal haze, aqueous humor transparency, increased intraocular pressure and self reported postoperative pain. Each item is scored 0-4: 0 = no symptom, 4 = severe symptom.
次要结局
- Visual acuity measured by LogMAR(12 months)
- Biocompatability, degree of haze and/or vascularisation measured on a scale 0-4(12 months)
研究者
Virender S Sangwan, MBBS, MS
Director, Center for Ocular Regeneration
L.V. Prasad Eye Institute