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临床试验/NCT06115005
NCT06115005Unknown2 期

Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

Minia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
40
试验地点
1
主要终点
Number of participants that revealed closure of challenging macular holes

研究概览

简要总结

Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

详细描述

Challenging full thickness macular holes ( FTMH) include :

Recurrent FTMH Persistent (refractory) FTMH Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm. Plasma rich in growth factors (PRGF) is characterized by a moderate concentration of platelets, in the absence of leukocytes.

This absence of leukocytes is based on the fact that they synthesize matrix metalloproteinases, free radicals, and proinflammatory cytokines, which do not contribute and even impair the altered tissue regeneration Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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
  • Challenging FTMH which include Recurrent macular holes Persistent(refractory) macular holes Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm

排除标准

  • 1-Corneal opacities 2-Glaucomatous patients 3-Co-existing macular pathology ( e.g. diabetic retinopathy, vein occlusion and age related macular degeneration ) 4-History of PPV for any reason other than FTMH

结局指标

主要结局

Number of participants that revealed closure of challenging macular holes

时间窗: 6 months

By clinical examination and OCT

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Mohamed Moharram

Professor Doctor

Minia University

研究点 (1)

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