Comparison of the Efficacy of Standard 25 Gauge (25G)+ and Beveled 27 Gauge (27G)+ Vitrectomy Systems in Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- the convenience in operating
研究概览
简要总结
In recent years, vitrectomy has moved toward a minimally invasive vitrectomy surgery (MIV) system, which could effectively reduce the occurrence of operation complications, while reducing the time of post-operation recovery.
With an improved design of bevel tip and a high cutting rate capacity of 10000cpm, Advanced ULTRAVIT® probes potentially provide an strong technical support for the application of MIV. The new probe facilitates great control during delicate surgical maneuvers, such as separating the hyaloid from the retinal surface, dissecting fibrovascular tissue off the surface of retina.
However, there was no sufficient clinical evidence to support the benefits of Advanced ULTRAVIT ® probes in the complicated vitreoretinal surgery, such as proliferative diabetic retinopathy. More importantly, there is an urgent need of clinical evidence to support 10000cpm launch and conversion which is major objective of 2021 VR growth strategies.
详细描述
This exploratory study, aiming to demonstrate the beneficial of 27 Gauge probe, which can be flexibly applied as a multifunctional tool for membrane removal by reducing frequencies of switching device, reducing the traction to eyeball during device entering and leaving the eye. Moreover, the outcomes from this study would be an strong evidence to support further comparative study to comprehensively demonstrate the superior function compare to current heavily used 5K 25 gauge probe.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with vitreous hemorrhage and tractional retinal detachment (TRD) confirmed by fundus image and B ultrasound examination, consistent with the diagnosis of severe proliferated diabetic retinopathy (PDR).
- •Patient that could follow up postoperatively at the clinic for 6 months more.
- •All the surgeries were performed by one well-experienced retinal surgeon.
排除标准
- •Corneal lesions affecting operative field, such as corneal opacity or scar; History of vitreoretinal surgery;
- •External eye infections;
- •History of systemic thromboembolism;
- •Uncontrolled hypertension or hyperglycemia;
- •Coagulation abnormalities or currently using anticoagulant drugs other than aspirin;
- •Unable to meet postoperative position requirements;
- •Unable to be followed up regularly.
结局指标
主要结局
the convenience in operating
时间窗: during surgery
The convenience will be indicated by times of ancillary instrument using, which evaluated based on the recorded surgical video.
the efficiency of stripping membrane
时间窗: during surgery
It will be measured by the area of membrane removed per minute by probe.
次要结局
- best corrected visual acuity (BCVA)(baseline to 6 months post-surgery)
研究者
Zhenchuan Zheng
Principal investigator
Tianjin Medical University Eye Hospital