跳至主要内容
临床试验/CTRI/2024/11/076447
CTRI/2024/11/076447尚未招募不适用

Disorganisation of inner vs outer retinal layers in predicting the response to ANTI-VEGF treatment in diabetic macular edema, an observational study

Department Of Ophthalmology , Kasturba Medical College , Manipal1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2024年11月14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
97
试验地点
1
主要终点
for the selected patients the baseline OCT,visual acuity and 1 month post 3 rd ANTI-VEFG (avastin-bevacizumab) injection visual acuity and OCT macula data will be collected from the medical records and interpreted .In addition to these other parameters like HBA1C, serum creatinine values will also be collected from medical records.

研究概览

简要总结

This is Retrospective Observational study. in which Role of disorganization of inner vs outer retinal layers in predicting the response to ANTI-VEGF treatment in diabetic macular edema will be studied.

·         Permission to access the records in the medical records department will be taken from The Medical Superintendent.

·         Description of process :Step 1- to obtain IEC and CTRI clearance

·         Step 2- We will retrospectively review the medical records of patients who had who met the inclusion criteria will be selected from the medical records and will be included in the study .And patients falling under exclusion criteria will be xcluded

·          Step 3- for the selected patients the baseline OCT,visual acuity and 1 month post 3 rd ANTI-VEFG injection visual acuity and OCT macula data will be collected from the medical records .In addition to these other parameters like HBA1C, serum creatinine values will also be collected from medical records.

·         Outcome measures: Outcome measures include effect of retinal outer and inner layers morphology on visual acuity and central retinal thickness.

·         Potential risks and benefits: There is less than minimal risk for patient as it was purely an retrospective study in which we collect data from medical redords and we don’t alter or introduce any other tests other than treatment plan. In this study role of disorganisation of retinal inner vs outer layers of retina in predicting response to anti-VEGF treatment in DME will be studied which might aid in predicting the disease prognosis and disease management.

·         We will only review the records from the medical records department who fit the inclusion criteria and no active intervention will be done.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All patients with Diabetic macular edema who underwent atleast 3 ANTI-VEGF (avastin-bevacizumab) whose 1 month post 3rd ANTI-VEGF injection OCT and vision was done from 1st jan 2022 to 20th may 2025 will be included.

排除标准

  • Patients without diabetes, baseline OCT and those younger than 18 years are excluded.
  • Patients with significant cataract, significant astigmatism, significant glaucoma that could effect OCT values will be excluded.
  • Patients with macular edema due to other causes will be excluded.
  • Patinets undergone treatment with OZURDEX will be excluded.

结局指标

主要结局

for the selected patients the baseline OCT,visual acuity and 1 month post 3 rd ANTI-VEFG (avastin-bevacizumab) injection visual acuity and OCT macula data will be collected from the medical records and interpreted .In addition to these other parameters like HBA1C, serum creatinine values will also be collected from medical records.

时间窗: 1 month post 3 rd ANTI-VEGF injection

次要结局

未报告次要终点

研究者

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

DrSulatha V Bhandary

Kasturba Medical College and Hospital,

研究点 (1)

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