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临床试验/CTRI/2025/07/090792
CTRI/2025/07/090792Not Applicable不适用

An Observational Study To Evaluate The Visual Outcome Of Internal Limiting Membrane Peeling Versus No Peeling During Vitrectomy For Diabetic Vitreous Hemorrhage

SMS Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年7月22日最近更新:

试验速览

阶段
不适用
状态
Not Applicable
发起方
入组人数
70
试验地点
1
主要终点
To evaluate the visual outcome of Internal Limiting Membrane peeling during vitrectomy versus no peeling in diabetic vitreous hemorrhage.

研究概览

简要总结

It is an observational study being conducted at SMS Medical college and Hospital ,at department of ophthalmology to evaluate the visual outcome of internal limiting membrane peeling versus no peeling in proliferative diabetic patients undergoing pars plana vitrectomy for the treatment of diabetic vitreous hemorrhage. Patients will be recruited from SMS eye OPD. All patient undergoing pars plana vitrectomy for diabetic vitreous hemorrhage will be included in study. pre op detailed ophthalmic assessment done includes visual acuity, tonometry and fundus evaluation. Decision to peel ILM determined by surgeon base on intra op condition. Post op visual assessment, tonometry and optical coherence tonography will be done at 1 week , 1 month and 3 months, and compare between ILM peeling and non ILM peeling was done. final visual acuity will be compared in both group internal limiting membrane peeling versus no peeling .

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient giving informed written consent.
  • Age group- 18 to 80 years.
  • Type 1 OR 2 Diabetes mellitus.
  • Vitreous hemorrhage secondary to PDR.
  • BCVA on snellen ranging from 20/40 to light perception with projection.

排除标准

  • Patient having underlying retinal detachment or extensive vitreoretinal adhesion.
  • Optic nerve or retina disorder unrelated to diabetes mellitus (glaucoma, optic neuritis, macular degeneration, etc.) NVG with elevated IOP (IOP greater than 30mmHg).
  • Medically uncontrolled systemic hypertension (systolic greater than 200 mmHg or diastolic greater than120 mmHg) despite antihypertensive therapy.
  • Previous history of vitrectomy.
  • Medically uncontrolled blood sugar despite treatment.
  • Diabetic nephropathy.

结局指标

主要结局

To evaluate the visual outcome of Internal Limiting Membrane peeling during vitrectomy versus no peeling in diabetic vitreous hemorrhage.

时间窗: To evaluate the visual outcome of Internal Limiting Membrane peeling versus no peeling during vitrectomy in diabetic vitreous hemorrhage at 1 week, 1 month and 3 month.

次要结局

  • To assess the central macular thickness on optical coherence tomography.(To assess the incidence of secondary epiretinal membrane.)

研究者

发起方
SMS Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Jyoti Nagar

SMS Medical College and Hospital, Jaipur

研究点 (1)

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