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临床试验/NCT04312620
NCT04312620Unknown不适用

Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling

Assiut University0 个研究点目标入组 10 人开始时间: 2020年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
主要终点
BCVA

研究概览

简要总结

To evulate changes in VF and OCT after viterctomy associated with ILM peeling.

详细描述

Macular epiretinal membrane (ERM) is a disorder of the vitreomacular interface characterized by fibrocellular proliferation on the anterior surface of the internal limiting membrane (ILM) of the macula. Pars plana vitrectomy with ERM removal and inner limiting membrane peeling is the standard surgical treatment for an ERM. ILM peeling is performed to eliminate the scaffold for myofibroblast proliferation and any microscopic ERM in order to prevent ERM recurrence. ILM peeling is indicated for other pathologies other than ERM such as, diabetic macular edema, and macular hole. ILM peeling is a traumatic procedure that may have many effects on the underlying inner retinal layers that may lead to changes in retinal function.

Retinal edema, eccentric scotoma, dissociation of the nerve fiber layer, iatrogenic punctuate chorioretinopathy, and subretinal, retinal, and vitreous hemorrhage are well described secondary to the surgical trauma of peeling in addition to stain toxicity. Investigation of these changes may assist in aiding the development of minimally traumatic techniques for ILM removal .

Evaluation of functional changes may include visual field and Multifocal electroretinography assessment. Visual field defect after vitrectomy a well known post operative complication usually in eyes that underwent fluid air exchange, the cause of visual field defect remain unclear.

Optical Coherence Tomography (OCT), imaging is done to evaluate inner retinal layers after ILM peeling,High myopic eyes might develop more severe, "scattered" inner retinal defects after ILM peeling.

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
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1-Idiopathic ERM,
  • Primary full thickness macular hole,
  • Lamellar macular hole, and
  • Vitromacular traction.

排除标准

  • 1-Patients with a secondary ERM,
  • diabetic retinopathy,
  • venous occlusion,
  • retinal detachment,
  • uveitis, and
  • trauma. 2-Other ocular pathologies that could interfere with the functional results
  • dense cataract ,
  • glaucoma, and
  • previous retinal surgery.

结局指标

主要结局

BCVA

时间窗: 6 months

ILM peeling

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

Almoatz bellah zohier Mohammed

doctor

Assiut University

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