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临床试验/NCT06919211
NCT06919211已完成不适用

Outcomes of Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment

Benha University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年1月15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
29
试验地点
1
主要终点
Retinal reattachment rates

研究概览

简要总结

Purpose To evaluate the outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications.

Methods This is a prospective randomized controlled trial that included 58 eyes with RRD, divided into Group A (PFCL, n = 29) and Group B (PR, n = 29). Preoperative assessments included best-corrected visual acuity (BCVA), IOP, axial length, lens status, macula status, and PVR grade. Outcomes were evaluated at 1 week, 1 month, 2 months, and 3 months postoperatively. Primary outcomes included retinal reattachment rates and the number of operations; secondary outcomes included BCVA, IOP changes, complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success.

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

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

  • •A clear diagnosis of primary RRD requiring surgery, 18 years or older, The potential to return for follow-up visits for at least 6 months post-surgery.

排除标准

  • •When presented with tractional or exudative retinal detachment, had surgery on the affected eye in the past, presented with severe eye disorders like advanced glaucoma or endophthalmitis.

研究组 & 干预措施

Posterior Retinotomy Group

Experimental

干预措施: Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment (Procedure)

Perfluorocarbon Liquid Group

Experimental

干预措施: Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment (Procedure)

结局指标

主要结局

Retinal reattachment rates

时间窗: One month, Two months, and Three Months

Number of operations

时间窗: One month, Two months, and Three Monthes

次要结局

  • Best-corrected visual acuity (BCVA)(One month, Two months, and Three Monthes)
  • Intraocular pressure (IOP)(One month, Two months, and Three Monthes)
  • Complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success(One month, Two months, and Three Monthes)

研究者

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

Ehab Mohamed Elsayed Mohamed Saad

Lecturer of Ophthalmologyو Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt

Benha University

研究点 (1)

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