跳至主要内容
临床试验/CTRI/2024/06/068825
CTRI/2024/06/068825尚未招募3 期

Use of microscopic integrated optical coherence tomography to reduce post-surgical epiretinal membrane formation in eyes undergoing vitrectomy for tractional retinal detachment due to diabetic retinopathy.

Advanced Eye Centre1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
we will compare the incidence of epiretinal membrane formation between group A and group B

研究概览

简要总结

Post-surgery epiretinal membrane formation (ERM) is a frequent complication associated with pars plana vitrectomy. Diabetic retinopathy poses an independent risk factor for the development of ERM. Despite extensive vitrectomy and membrane peeling, the incidence of postoperative ERM was found to be 21.7–52.8%.

It has been suggested that ILM peeling can reduce ERM production and diabetic macular edema in diabetic eyes. The introduction of microscope integrated optical coherence tomography (MIOCT) is reported to provide valuable inputs peculiarly during identification of dissection plane, membrane peeling, identification of residual membranes and underlying epiretinal membranes.

Ours will be a prospective, randomized, interventional study. All patients presenting to AEC, PGIMER, Chandigarh with diagnosis of diabetic TRD threatening or involving macula will be included in the study, after obtaining written informed consent. The study will be following the Declaration of Helsinki guidelines for research involving human subjects.

Patients fulfilling the inclusion criteria will be recruited for the study after written informed consent and will be randomized into 2 groups by a coin toss on the day before surgery. Heads= group A, Tails = group B. The surgeon will be blinded from the pre-operative and post-operative details, and the person performing analysis will be separate from the operating team and clinical team.

All the surgeries will be done by a single surgeon with more than 18-years’ experience in vitreoretinal surgery. All patients will receive preoperative ranibizumab intravitreal injection 3 to 5 days prior to surgery. In Group A patients, MIOCT will be used to look for the preretinal membranes in the macular area at the end of surgery to look for preretinal residual membranes. They will be removed intraoperatively using MIOCT. While Group B patients will undergo ILM peeling (2 disc diameter) using BBG staining (0.25mg/ml) followed by immediate washout to make sure that all preretinal membranes have been removed. We will be using laser photocoagulation and/or cryotherapy at port sites, and internal tamponade with air or gas depending on the intraoperative requirements.

Follow up of each patient will be done at postoperative day 1, 1 week, 1 month and at 3 months. At each follow up patients are subjected to BCVA measurement, IOP measurement, anterior and posterior segment examination. Media clarity, retina status and presence of post-operative vitreous cavity haemorrhage (POVCH) will be documented.

There is lack of comparative and randomized study, comparing the role of MIOCT and ILM peeling to prevent post-surgery ERM formation in TRD eye of diabetes patients undergoing PPV. In this study, we will evaluate the role of MIOCT to reduce post-surgical ERM in eyes undergoing PPV for TRD due to diabetic retinopathy.

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, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • type 1 and 2 DM who require vitrectomy for diabetic TRD willing for preoperative injection of Ranibizumab phakic or pseudophakic willing for follow up period of 3 months.

排除标准

  • aphakic patients NVI/NVG history of prior vitrectomy combined retinal detachment requiring silicone oil tamponade in case of intraoperative break formation unwilling for preoperative injection of Ranibizumab history of stroke/MI 3 months before injection of Ranibizumab unable to maintain a particular posture after surgery, if required unwilling to be a part of the study.

结局指标

主要结局

we will compare the incidence of epiretinal membrane formation between group A and group B

时间窗: day 1, 1 week, 1 month and at 3 months.

group A- MIOCT will be used at the end of surgery to look for preretinal residual membranes. They will be removed intraoperatively using MIOCT.

时间窗: day 1, 1 week, 1 month and at 3 months.

group B- conventional ILM peeling group

时间窗: day 1, 1 week, 1 month and at 3 months.

次要结局

  • comparison of visual gain and any complications such as postoperative vitreous cavity haemorrhage between the two groups(at 3 months)

研究者

发起方
Advanced Eye Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DIVYA CHAUHAN

Post graduate institute of medical education and research, Chandigarh

研究点 (1)

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