跳至主要内容
临床试验/CTRI/2024/12/077637
CTRI/2024/12/077637尚未招募不适用

A Retrospective study to find the association between OCT biomarkers of Idiopathic Epiretinal Membrane and Visual Acuity

Department of Ophtalmology Kasturba Medical College Manipal1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年12月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
This study aims to bring forth the often ignored parameters that are seen on OCT in patients with Idiopathic Epiretinal membrane and this understanding will help guide the treatment plan of the patients in the future by means of acting as a more reliable indicator of the patient’s visual prognosis. It will also help ascertain the urgency of surgical intervention in the patient

研究概览

简要总结

Objective:

A retrospective study to find an association  between the OCT biomarkers of Idiopathic Epiretinal Membrane and the patient’s Visual Acuity.

Materials and methods:

As per the protocol of treating patients who are diagnosed to have Idiopathic Epiretinal Membrane, an important aspect of managing the disease are follow ups. Patients are called every 6 months for follow ups to the OPD, wherein in each visit their Visual Acuity, OCT and Dilated fundus examination is done so as to assess the progression of the disease and plan intervention accordingly. The study is a Retrospective analysis comparing the OCT biomarkers of patients who have been receiving treatment for Idiopathic Epiretinal membrane with the patient’s visual acuity recorded within a time span of 1 month of their OCT. Medical records of the patients who fulfill the Inclusion criteria will be selected. Data of the visual acuity of the patients will be obtained from the medical records. It will then be converted from Snellen’s format to LOGMAR scale. The analysis of the OCT biomarkers from the medical records will be done by 2 independent observers and compared with the visual acuity

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Presence of Unilateral or Bilateral Epiretinal Membrane whose aetiology cannot be traced back to any disease.

排除标准

  • 1.Epiretinal membrane secondary to any previous ocular surgery, any trauma to the eye, any systemic co-morbidity like Diabetes mellitus leading to Proliferative and Non-proliferative diabetic retinopathy.
  • 2.Any ocular infection or any non -infectious inflammatory condition of the eye.
  • 3.History of Retinal Detachment (traumatic/exudative/rhegmatogenous) 4.Known case of Advanced Glaucoma or Optic Neuropathy 5.Patients diagnosed with any other cause of vision loss other than Epiretinal Membrane.

结局指标

主要结局

This study aims to bring forth the often ignored parameters that are seen on OCT in patients with Idiopathic Epiretinal membrane and this understanding will help guide the treatment plan of the patients in the future by means of acting as a more reliable indicator of the patient’s visual prognosis. It will also help ascertain the urgency of surgical intervention in the patient

时间窗: Assessment of the data of the patient at their first visit, followed by assessment at 3 to 6 months time interval from the first visit

次要结局

  • Analysis of subjects with two sequential OCTs done with a time interval of 3 to 6 months between them, to assess the longitudinal changes in the OCT biomarkers & to determine which Biomarker is associated with worse Visual Acuity.(Assessment of the data of the patient at their first visit, followed by assessment at 3 to 6 months time interval from the first visit)

研究者

发起方
Department of Ophtalmology Kasturba Medical College Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shailaja S

Kasturba Medical College, Manipal

研究点 (1)

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