A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The anatomical retention rate will be calculated and presented as the number of
研究概览
简要总结
The CorNeat KPro is a patented synthetic corneal implant (keratoprosthesis) developed to provide a long-lasting medical solution for corneal blindness, pathology, and injury. The CorNeat KPro is designed to provide an accessible, efficient, effective, and reliable remedy for people with cornea-related visual impairments. The CorNeat KPro utilizes a novel polymeric bio-integrating skirt to assimilate synthetic optics within resident ocular tissue. Other currently available solutions rely either on donor tissue (keratoplasty), or synthetic implants mounted on biological carrier tissues and then attached to the native corneal tissue – a tissue lacking blood vessels and healing capacity. In contrast, the CorNeat KPro integrates seamlessly with the eyewall, underneath the conjunctiva, and over the sclera where scarring potential is maximal. The CorNeat KPro Implantation Kit (“the deviceâ€) comprises the CorNeat KPro and a toolset.
This product is under clinical investigation worldwide and is risk classified as, Class C (Sterile). As per Indian Regulations, also it falls under the High-Risk classification of Class C since it is a permanent ocular implant
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged ≥ 21 and ≤ 80 years on the day of screening
- •Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
- •Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes.
- •In case of unilateral blindness – BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eye
- •Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation
- •Indications that fall under poor candidate for keratoplasty include but are not limited to scarred cornea following transplantation failure, which can be either vascularized, limbal stem cell-deficient and/or following burn/trauma
- •Adequate tear film and lid function
- •Perception of light in all quadrants
- •Female patients of childbearing age must have a negative pregnancy test at screening and agree to use an effective method of contraception throughout the study.
排除标准
- •Reasonable chance of success with traditional keratoplasty
- •Current retinal detachment
- •Connective tissue diseases or severely scarred conjunctiva in the target eye
- •End-stage glaucoma or evidence of current uncontrolled glaucoma
- •History or evidence of severe inflammatory eye diseases (i.e., conjunctivitis, uveitis, retinitis, scleritis)
- •History of ocular or periocular malignancy
- •History of extensive keloid formation
- •Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or components of the device
- •Ocular ischemic syndrome.
结局指标
主要结局
The anatomical retention rate will be calculated and presented as the number of
时间窗: Throughout 24 months post-op
patients with retained device out of the total number of patients at the respective
时间窗: Throughout 24 months post-op
follow up visit. To clarify, anatomical retention refers to whether the device remains in
时间窗: Throughout 24 months post-op
place and intact within the eye. This will be evaluated by the presence or absence of
时间窗: Throughout 24 months post-op
complications such as device extrusion, endophthalmitis, or glaucoma.
时间窗: Throughout 24 months post-op
次要结局
- Best Corrected Distant Visual Acuity will be determined using ETDRS visual acuity chart,(where applicable, at each of the follow up visits throughout the trial’s duration and will)
研究者
Dr Virender Singh Sangwan
Dr Shroffs Charity Eye Hospital