跳至主要内容
临床试验/CTRI/2024/08/073023
CTRI/2024/08/073023尚未招募2 期

Comparing the Anatomical and Functional outcome of Total ILM peeling versus Hemi-temporal ILM peeling in Macular Hole surgery

Dr Prabha Siddaraju1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Difference in Anatomical hole closure between Total ILM peeling v/s Hemi-temporal ILM peeling in macular hole surgery by Fundus photography & En Face OCT/ OCTA

研究概览

简要总结

1.Hemi-temporal ILM peeling is as effective and safe conventional full peeling for macular hole surgery.

2.Complications of ILM peeling alone- Retinal Thinning, DONFL ( dissociation of optic nerve fiber layer)

Complications due to dye- chemical trauma.

Complications due tamponading agents- Glaucoma, Cataract.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Idiopathic full thickness macular hole.
  • PPV with ILM peeling.
  • Total peel and Hemi-temporal ILM peeling
  • Tamponading agents of surgeons choice.
  • Quantitative data on our outcome.

排除标准

  • 1.Secondary Macular hole due to – MYOPIC, DEGENERATIVE AND TRAUMATIC.
  • 2.Partial thickness macular hole.
  • 3.Other ocular abnormality – glaucoma, ARMD, diabetic retinopathies and retinal vascular disease.
  • 4.Previous vitrectomy for macular holes and with persistent or reopened holes.

结局指标

主要结局

Difference in Anatomical hole closure between Total ILM peeling v/s Hemi-temporal ILM peeling in macular hole surgery by Fundus photography & En Face OCT/ OCTA

时间窗: 1 week and 4 weeks

次要结局

  • To correlate functional outcome in patients who developed DONFL -(- BCVA)

研究者

发起方
Dr Prabha Siddaraju
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Prabha Siddaraju

Sankara eye hospital

研究点 (1)

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