Étude Clinique Ouverte et Prospective évaluant la sécurité et l'efficacité de la cornée biosynthétique CLP-PEG-MPC Chez Les Patients nécessitant Une kératoplastie Lamellaire antérieure Profonde à Haut Risque.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- conjunctival inflammation
研究概览
简要总结
This is an open-label and prospective clinical trial, in which a maximum of 5 eyes of 5 patients will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) surgery and will be followed up over 24 months.
详细描述
This is a prospective open-label clinical trial of patients who will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) corneal transplantation surgery and be followed over 24 months. The primary objective is to demonstrate the safety and tolerability of CLP-PEG-MPC biosynthetic corneal implants. The secondary objective is to examine the preliminary efficacy of these implants to stimulate corneal tissue regeneration, provide optical clarity and improvement of vision. Randomization is not appropriate in a first-in-human pilot study. Blinding is not possible as surgeons can easily tell a cell-free implant apart from a donor allograft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult age (18 years or older at the time of subject eligibility visit)
- •able to provide signed, informed consent
- •unilateral corneal opacity not involving the posterior corneal layers (Descemet membrane and endothelium) for which DALK is indicated
- •visual acuity less than 20/200 in the affected eye and better than 20/50 in the contralateral eye (i.e. monocular blindness)
- •presence of at least one of the following high-risk criteria for corneal transplantation using a human cornea donor graft: 5i) inflammation 5ii) active infection 5iii) stromal neovascularization 5iv) neurotrophism 5v) autoimmune disease 5vi) previous DALK graft failure
- •availability for 24 months of postoperative follow-up
排除标准
- •Age under 18 years
- •Inability to give informed consent
- •Previous corneal perforation precluding DALK surgery
- •Endothelial pathology requiring penetrating keratoplasty
- •Limbal stem cell deficiency affection more than 50% of the limbus
- •Previous penetrating or endothelial keratoplasty
- •Bilateral blindness
- •Uncontrolled glaucoma or intraocular pressure
- •Documented macular disease (age-relate macular degeneration, macula-involving retinal detachment, macular hole)
- •Documented amblyopia of surgical eye
结局指标
主要结局
conjunctival inflammation
时间窗: 24 months
bulbar conjunctival inflammation (scale 0-none to 4-worse)
visual acuity - best-spectacle correction
时间窗: 24 months
best-spectacle corrected visual acuity
complications
时间窗: 24 months
occurence of implant-related complications
visual acuity - uncorrected
时间窗: 24 months
uncorrected visual acuity
intraocular inflammation
时间窗: 24 months
anterior uveitis (SUN classification of cell and flare for anterior uveitis)
次要结局
- corneal sensation(24 months)
- Refraction(24 months)
- ocular pain(24 months)
- corneal thickness(24 months)