跳至主要内容
临床试验/NCT07633457
NCT07633457招募中不适用

Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月9日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1

研究概览

简要总结

The aim of this study is to compare the functional visual outcomes, anatomical closure rate and macular perfusion changes assessed by OCT and OCTA after surgical repair of macular hole using Tenon capsule graft versus ILM flap.

详细描述

Macular hole (MH) is a full-thickness defect of the neurosensory retina at the fovea, causing central visual loss. The incidence of idiopathic MH increases with age and is more common in females. Vitreomacular traction is the main pathophysiological factor leading to MH formation.

Pars plana vitrectomy with internal limiting membrane (ILM) peeling has been considered the standard technique for MH repair, achieving high anatomical closure rates. However, for large and refractory holes, conventional ILM peeling may not be sufficient.

The inverted ILM flap technique was developed as an alternative for large MHs (≥400 µm). This method allows the peeled ILM to be inverted and placed over the hole to serve as a scaffold for glial proliferation, enhancing closure rates and improving visual outcomes.

More recently, Tenon capsule graft has been introduced as an autologous biological scaffold for macular hole closure. Tenon tissue is rich in fibroblasts and extracellular matrix, which may promote retinal repair and facilitate closure in cases resistant to conventional approaches.

Optical coherence tomography (OCT) has become essential for evaluating macular hole dimensions, classifying stages, and confirming closure after surgery. It provides high-resolution images that allow detailed morphologic analysis.

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

入选标准

  • Patients diagnosed with idiopathic full-thickness macular hole
  • ≥400 µm in horizontal diameter

排除标准

  • Media opacity preventing adequate OCT/OCTA imaging
  • Other retinal vascular pathology as retinal vascular occlusion
  • Intraoperative complications
  • Signal noise ratio using OCTA <6\10
  • Poor fixation of the patient

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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