NCT04557527已完成不适用
Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment: A Randomized, Controlled, Feasibility Trial
King's College Hospital NHS Trust12 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 12
- 主要终点
- To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle.
研究概览
简要总结
The study compares standard surgery for retinal detachment (RD) (vitrectomy, cryotherapy and gas) with a surgical variation that replaces the intraocular gas tamponade with suprachoroidal injection of viscoelastic underneath the break that caused the retinal detachment.
详细描述
After being informed about the study and the potential risks, the eligible patients who have given written consent to the treatment will be randomized into treatment (vitrectomy, cryo and gas) or control (viscobuckle vitrectomy) group.
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
盲法说明
randomisation software
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
- •Patients requiring pars plana vitrectomy for the treatment of primary rhegmatogenous retinal detachment (RD) caused by a single break, or multiple breaks within one clock hour. The final determination of qualifying breaks is made at the time of surgery following 360-degree, internal, indented search using a wide-angle viewing system.
排除标准
- •Hypersensitivity to hyaluronate or. HEALON5® PRO OVD
- •Participation in another interventional study within 8 weeks of enrolment or planned to occur during this study.
- •Bleeding disorders or the use of anticoagulants (such as warfarin, rivaroxaban) or dual anti-platelet drugs such as aspirin with clopidogrel. Monotherapy with low dose (≤100 mg) aspirin is permitted, and if clinically appropriate this should be stopped prior to surgery and recommenced only after satisfactory day 1 post-operative review.
- •Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.
- •Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical disease.
- •Presence of proliferative vitreoretinopathy (PVR) or any tractional RD
- •Previous vitreoretinal surgery, open-globe injury or endophthalmitis
- •Previous or current congenital cataract
- •Previous or current suprachoroidal haemorrhage
- •Congenital or acquired ocular, orbital or periocular abnormality that, in the opinion of the attending vitreoretinal surgeon, would preclude the safe delivery of Healon 5 into the suprachoroidal space (detail the specific reason for exclusion in the source documents)
- •Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to prevent an accurate assessment of retinal attachment
- •Current intraocular inflammation other than mild cellular activity thought to be secondary to RD
- •Current ocular or periocular infection other than blepharitis
结局指标
主要结局
To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle.
时间窗: 2 years
feasibility trial
To establish if it is feasible to recruit, retain, and evaluate patients with RD into a larger randomised controlled trial of vitrectomy and suprachoroidal viscobuckle.
时间窗: 2 years
feasibility trial
次要结局
未报告次要终点
研究者
研究点 (12)
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