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临床试验/NCT07038668
NCT07038668尚未招募不适用

The Innovative Appliance of Cohesive Viscoelastic During Pars Plana Vitrectomy in Complicated Ocular Trauma

Zhongshan Ophthalmic Center, Sun Yat-sen University0 个研究点目标入组 420 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
420
主要终点
Best Corrected Visual Acuity(BCVA)

研究概览

简要总结

Viscoelastic is a powerful tool in pars plana vitrectomy(PPV) surgery relative to perfluorocarbon liquid because it has the properties to dilate and engorge the retina and restore the detached retina to its original position. We intend to explore whether the use of viscoelastic to assist PPV surgery can help improve surgical efficiency, reduce tissue damage, and improve the outcomes of the patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Severe traumatic ocular injury (ocular trauma score, OTS=1 or 2)
  • PVR retinal detachment (Stage D2 or D3)

排除标准

  • Visual acuity below the base line before injury

结局指标

主要结局

Best Corrected Visual Acuity(BCVA)

时间窗: From enrollment to the end of follow up in 3 months

Best Corrected Visual Acuity

Reattachment of Retina

时间窗: Post operation till the end of follow up in 3 months

Check through ultrasound, optical coherence tomography(OCT) to see if retina is reattached.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xueying Zhongliu

Clinical Professor

Zhongshan Ophthalmic Center, Sun Yat-sen University

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