FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/08/044521 [Registered on: 01/08/2022] Trial Registered Prospectively
Last Modified On: 26/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of electrical activity of retina between diabetic patients with and without fluid accumulation in the centre of retina 
Scientific Title of Study   Electroretinogram changes in diabetic patients with and without Diabetic Macular Edema 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shana K 
Designation  Junior resident ophthalmology 
Affiliation  Sankara eye hospital, Coimbatore 
Address  Sankara eye hospital Sathy road Sivanandhapuram Coimbatore TamilNadu

Coimbatore
TAMIL NADU
641035
India 
Phone  7772960052  
Fax    
Email  shanakadakot@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prabhu Shanker M 
Designation  Senior consultant, Retina 
Affiliation  Sankara eye hospital, Coimbatore 
Address  Sankara eye hospital Sathy road Sivanandhapuram Coimbatore TamilNadu

Coimbatore
TAMIL NADU
641035
India 
Phone  9443186568  
Fax    
Email  drprabhushanker@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prabhu Shanker M 
Designation  Senior consultant, Retina 
Affiliation  Sankara eye hospital, Coimbatore 
Address  Sankara eye hospital Sathy road Sivanandhapuram Coimbatore TamilNadu

Coimbatore
TAMIL NADU
641035
India 
Phone  9443186568  
Fax    
Email  drprabhushanker@gmail.com  
 
Source of Monetary or Material Support  
Sankara eye hospital Sathy road Sivanandhapuram Coimbatore 641035  
 
Primary Sponsor  
Name  Sankara eye hospital Coimbatore 
Address  Sankara eye hospital Sathy road Sivanandhapuram Coimbatore TamilNadu 641035 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shana K  Sankara eye hospital, Coimbatore  Sathy road Sivanandhapuram Coimbatore, TamilNadu 641035 Department of retina
Coimbatore
TAMIL NADU 		 7772960052

shanakadakot@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  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 - controls
 
 
ExclusionCriteria 
Details  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)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ERG patterns in diabetic patients with and without diabetic macular edema  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Best corrected visual acuity(BCVA) and foveal thickness on spectral domain OCT(SD-OCT)

 		 At baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.



 
Close