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临床试验/NCT05367193
NCT05367193已完成不适用

Surgical Outcomes and Intraoperative Parameters Evaluation of 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Number of injections of ICG

研究概览

简要总结

To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes

详细描述

The investigators aimed to compare the safety and efficacy of NGENUITY® 3D Visualization System (Alcon, TX, USA) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. This is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. The enrolled patients will be randomized into "NGENUITY® 3D Visualization System (Alcon, TX, USA) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). The investigators will compare the number of injections of dye (indocyanine green (ICG) or brilliant blue G (BBG)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (IOP), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (BCVA), structural changes shown on OCT and so on between the two groups.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Highly myopic patients (axial length ≥ 26mm, no upper limit)
  • •Patient with vitreoretinal pathology that require vitrectomy who had not received previous ICG or BBG-assisted membrane peeling
  • •Patient aged ≥ 20 years

排除标准

  • •Patient who had previous ICG or BBG-assisted membrane peeling
  • •Patient who received combined vitrectomy and trabeculectomy
  • •Patient with endophthalmitis or intraocular foreign body

研究组 & 干预措施

pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)

Experimental

NGENUITY® 3D Visualization System (Alcon, TX, USA)

干预措施: pars plana vitrectomy (Procedure)

pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)

Experimental

NGENUITY® 3D Visualization System (Alcon, TX, USA)

干预措施: NGENUITY® 3D Visualization System (Alcon, TX, USA) (Device)

standard binocular microscope pars plana vitrectomy

Active Comparator

standard binocular microscope pars plana vitrectomy

干预措施: pars plana vitrectomy (Procedure)

结局指标

主要结局

Number of injections of ICG

时间窗: operation day

Fixed and minimal concentration: ICG (25mg/vial) is diluted to 0.05% Fixed time: Each injection is 15 sec Interval time for washout: consistent as 10 sec

次要结局

  • ICG exposure time(operation day)
  • ILM peeling time(operation day)
  • Total surgical time(Intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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