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临床试验/NCT07318961
NCT07318961招募中不适用

Visual and Anatomical Outcomes of Autologous Tenon's Capsule Graft for Refractory Macular Holes

Benha University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Macular hole anatomical closure

研究概览

简要总结

This prospective interventional study evaluates the anatomical and functional outcomes of autologous Tenon's capsule grafting in patients with refractory full-thickness macular holes. Eligible patients include those with chronic large macular holes (>400 µm) or persistent holes following prior pars plana vitrectomy with internal limiting membrane peeling and gas tamponade. Anatomical closure will be assessed using spectral-domain optical coherence tomography, and functional outcomes will be evaluated by best-corrected visual acuity over a 3-month follow-up period.

详细描述

Refractory full-thickness macular holes represent a significant surgical challenge, with reduced closure rates following conventional techniques, particularly in large or chronic defects. Autologous tissue grafting has emerged as an alternative strategy to provide a biological scaffold for retinal tissue bridging and gliosis. Tenon's capsule is a readily accessible autologous fibrovascular tissue that can be harvested intraoperatively with minimal morbidity.

This prospective single-arm clinical study aims to assess the anatomical closure rate and visual outcomes following autologous Tenon's capsule graft placement in refractory macular holes. All patients will undergo standard pars plana vitrectomy, placement of a trimmed Tenon's graft into the macular hole, and silicone oil tamponade. Outcomes will be evaluated using standardized visual acuity testing and spectral-domain OCT imaging at predefined postoperative intervals.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Age 18 years or older
  • Refractory full-thickness macular hole defined as:
  • Chronic macular hole >400 µm, or
  • Persistent macular hole following prior vitrectomy with ILM peeling and gas tamponade
  • Clear ocular media and adequate fixation for OCT imaging
  • Ability to provide informed consent

排除标准

  • Active ocular infection or inflammation
  • Advanced glaucoma or optic neuropathy
  • History of intraocular tumors
  • Severe proliferative vitreoretinopathy
  • Significant systemic diseases likely to affect visual recovery

研究组 & 干预措施

Autologous Tenon's Capsule Graft

Other

Procedure

干预措施: Autologous Tenon's Capsule Graft Placement (Procedure)

结局指标

主要结局

Macular hole anatomical closure

时间窗: 3 months postoperatively

Complete closure of the macular hole as confirmed by spectral-domain OCT

次要结局

  • Change in Best-Corrected Visual Acuity (logMAR)(Baseline (preoperative), 1 month postoperatively, and 3 months postoperatively)

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

Benha University

研究点 (1)

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