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临床试验/CTRI/2022/08/044521
CTRI/2022/08/044521尚未招募不适用

Electroretinogram changes in diabetic patients with and without Diabetic Macular Edema

Sankara eye hospital Coimbatore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月8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
60
试验地点
1
主要终点
ERG patterns in diabetic patients with and without diabetic macular edema

研究概览

简要总结

•Diabetic macular edema(DME) is the most common cause of vision loss in patients with diabetic retinopathy and is increasing in prevelance globally.

•It has been reported that 20% and 14% of subjects with type 1 and 2 diabetes mellitus develop diabetic macular edeme(DME) respectively.

•There is impaired function in the middle and inner layers of the retina in diabetic patients before start of vascular complications. Therefore, there is a need for an objective test for early detection and diagnosis of DR and DME

•Traditional flash ERG (FERG) devices and multifocal ERG (mfERG) devices are time consuming to use, also these devices require pupil dilatation , the use of invasive corneal electrodes and professional analysis

•Recently a portable full-field ERG recording device called the RETeval system was introduced, the advent of which has made it easier to make general judgments about retinal function which has the following advantages:

ü     It is a small , handled device

ü     Non invasive : uses special skin electrode to record the ERG patterns

ü     No need for dilatation of pupil

ü     Testing time for both eyes is <5mins

The DR risk  assessment protocol which is provided by the manufacturer was used. A 30-Hz flicker ERG, as set in the electrophysiological standard by the International Society for Clinical Electrophysiology of  Vision (ISCEV) , will be used to observe the cone cell response.

The study presented herein compares the changes in the flicker electroretinography pattern between diabetic patients with and without diabetic macular edema.

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

  • 1 ) Age above 18 years 2) Patients diagnosed with type I or type II diabetes mellitus 3) Patient with clear media 4) Patients with confirmed DME having NPDR or PDR – cases 5) Patients with DM(diabetes mellitus) , no DR and DME.

排除标准

  • 1 ) Prior history of intravitreal injections 2) Prior history of retinal lasers 3) Significant media opacity 4) Prior history of retinal detachment 5) Prior history of vitrectomy 6) Centre involving diabetic macular edema (that may require imminent treatment) 7) Ocular abnormality that might impact ERG measurements (including more than 3 diopters of myopia).

结局指标

主要结局

ERG patterns in diabetic patients with and without diabetic macular edema

时间窗: At baseline

次要结局

  • Best corrected visual acuity(BCVA) and foveal thickness on spectral domain OCT(SD-OCT)

研究者

发起方
Sankara eye hospital Coimbatore
申办方类型
Private hospital/clinic

研究点 (1)

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