Comparison of electrical activity of retina between diabetic patients with and without fluid accumulation in the centre of retina
- Conditions
- Retinal disorders in diseases classified elsewhere,
- Registration Number
- CTRI/2022/08/044521
- Lead Sponsor
- Sankara eye hospital Coimbatore
- Brief Summary
•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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
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).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ERG patterns in diabetic patients with and without diabetic macular edema At baseline
- Secondary Outcome Measures
Name Time Method Best corrected visual acuity(BCVA) and foveal thickness on spectral domain OCT(SD-OCT)
Trial Locations
- Locations (1)
Sankara eye hospital, Coimbatore
🇮🇳Coimbatore, TAMIL NADU, India
Sankara eye hospital, Coimbatore🇮🇳Coimbatore, TAMIL NADU, IndiaShana KPrincipal investigator7772960052shanakadakot@gmail.com