Evaluating Efficacy and Safety of Medium-chain Triglycerides Used as a Temporary Intraocular Tamponading Agent for Retinal Detachment Treated by Endocular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Efficacy (tamponment efficacy supported by a flatten retina observation)
研究概览
简要总结
Background : Surgery is needed in order to flatten and position a detached retina onto the choroid, to allow sealing of the tears and to prevent or reverse vision loss. In case of complex retinal detachment vitrectomies followed by ocular endotamponade - non-solid implants used in ophthalmology - is the most common treatment. Despite several options used by surgeons were not entirely satisfactory, no innovation were marketed in the ocular endotamponade field since decades.
Purpose : Regarding comparative physico-chemical properties of medium-chain triglycerides (MCT) with current tamponading agents (silicone oil or gases), it will be proposed to evaluate the MCT as an ocular endotamponade product.
详细描述
Previously a nonclinical study has provide an assessment of the safety and the local tissue effects of the Medium-Chain Triglyceride (MCT) tamponade agent manufactured by the company Arcadophta : There were no histopathologic findings or irritation events that were directly attributable to the MCT device. In conclusion, under the conditions of the study, the MCT device did not induce any adverse local tissue effects compared to a control tamponading agent silicone oil.
The present clinical study is the first use of MCT tamponade agent which assigns human participants. The MCT tamponade agent studied is manufactured by the company Arcadophta and designed as a Class IIb medical device in Europe.
Tamponment efficacy and human eye safety of the device are supported by a flatten retina observation and a healthy eye fundus exam respectively as long as the tamponade agent is present.
The patient treatment is the classical surgical procedure which is used for retinal detachment with silicone oil.
- Vitrectomy, then flattened retina, and finally MCT injection in place of the vitreous.
- MCT ablation after 4 to 6 weeks (after effective retinopexy) The patient follow-up begins 4 days before treatment , then 3 time-points exams are performed before MCT ablation and 4 time-points exams are performed after MCT ablation for a total patient follow-up duration of 6 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient with retinal detachment which requires a classical surgical procedure with silicone oil.
- •Proliferative vitreoretinopathy over C2 regarding Retina Society classification
- •Retinal detachment due to trauma to the eye
- •Retinal detachment due to equatorial wound dehiscence which requires a classical surgical procedure with silicone oil.
- •Retinal detachment due to complex proliferative diabetic retinopathy
- •Recurrence of retinal detachment after ophthalmic gaz treatment
- •Retinal detachment due to giant tear (>90°C independently of the location into the eye.
排除标准
- •monophthalmic patient
- •Eye with corneal dystrophy
- •Intraocular pressure > 25 mmHg under treatment
- •Patient with travel difficulty or living place far away from the clinic
- •Patient participating to another clinical study.
- •Pregnant women or breastfeeding women
- •Patient under tutors or curators
结局指标
主要结局
Efficacy (tamponment efficacy supported by a flatten retina observation)
时间窗: 6 month
Flatten retina observation by fundus exam
次要结局
- Efficacy (ablation facility of MCT oïl)(6 weeks)
- Safety (Inflammation)(6 month)
- Cataract presence (lens opacity classification system III)(6 month)
- Efficacy (injection facility of MCT oïl)(Inclusion day : Day 0)
- Presence of hypertonia (intraocular pressure)(6 month)
- distance visual acuity measure to evaluate safety of MCT oil(6 month)
- Safety (MCT emulsification)(6 month)
- presence of micro-bubbles after post MCT ablation assessed according to a 5-point scale(6 month)
- Keratopathy presence to evaluate safety of MCT oil(6 month)