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CTRI Number  CTRI/2020/10/028396 [Registered on: 13/10/2020] Trial Registered Prospectively
Last Modified On: 12/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Changes in Retinal Blood Vessels seen in Diabetic Retinopathy and following its treatment 
Scientific Title of Study   Effect of Diabetic Retinopathy and its treatment on Macular Capillary Network Density 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirtika Jain 
Designation  Resident (DNB) Ophthalmology 
Affiliation  Sankara Eye Hospital, Bangalore 
Address  Sankara Eye Hospital, Varthur Main Road, Kundanahalli Gate, Bangalore

Bangalore
KARNATAKA
560037
India 
Phone  7999725070  
Fax    
Email  drkirtikajain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Minija C K 
Designation  Senior Consultant in Medical Retina and Uveitis 
Affiliation  Sankara Eye Hospital, Bangalore 
Address  Department of Retina, Room number-26, Sankara Eye Hospital, Varthur Main Road, Kundanahalli Gate, Bangalore

Bangalore
KARNATAKA
560037
India 
Phone  9480587018  
Fax    
Email  minija_ck@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kirtika Jain 
Designation  Resident (DNB) Ophthalmology 
Affiliation  Sankara Eye Hospital, Bangalore 
Address  Sankara Eye Hospital, Varthur Main Road, Kundanahalli Gate, Bangalore

Bangalore
KARNATAKA
560037
India 
Phone  7999725070  
Fax    
Email  drkirtikajain@gmail.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital, Bangalore 
 
Primary Sponsor  
Name  Sankara Eye Hospital Bangalore 
Address  Sankara Eye Hospital, Varthur Main Road, Kundanahalli gate, Bangalore (560037) 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kirtika Jain  Sankara Eye Hospital, Bangalore  Department of Retina, Room number- 26, Sankara Eye Hospital, Varthur Main Road, Kundanahalli Gate, Bangalore (560037)
Bangalore
KARNATAKA 		 7999725070

drkirtikajain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-SANKARA EYE HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age Group- 30 years to 60 years of age 
Patients  (1) ICD-10 Condition: E103||Type 1 diabetes mellitus with ophthalmic complications, (2) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients within Age group of 30 years to
60 years
2.Patients with Non-Proliferative Diabetic Retinopathy (NPDR)(Both Type1 and Type2 Diabetes Mellitus)
3. Patients with Diabetes with no evidence of Diabetic Retinopathy
4.Patients with NPDR with Centre involving Macular Edema undergoing treatment 
 
ExclusionCriteria 
Details  1. Patients with Proliferative Diabetic Retinopathy(PDR)
2. Patients with Non-centre involving Macular Edema
3. Lens or other media opacity which precludes imaging
4. Clinical evidence of other ocular or retinal pathology
5. Patients undergone previous treatment(Intravitreal injection or laser)
6. Patients with diabetic Tractional retinal detachement or Complete retinal detachment (TRD/CRD) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess changes in the Macular Capillary Vessel Density in patients with Diabetic Retinopathy and following treatment  baseline and 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess if there is any association between vessel density and HbA1c levels
2. To evaluate association of vessel density with visual acuity
3. To assess changes in the Central Retinal Thickness  		 baseline and 6 months 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   17/10/2020 
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="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   India is diabetic capital of world, with prevalence reaching nearly 70 million by 2025. Diabetes mellitus (DM) is a chronic metabolic disorder with several related systemic complication. Diabetic retinopathy (DR) is a common and specific microvascular complication of DM. Incidence of DR is on a rise and it nearly affects one third of patients with DM.

DR is a microangiopathy characterized by pericyte loss, thickening of basement membrane, formation of microaneurysms, and breakdown of blood retinal barrier.
These microvascular changes leads to capillary occulsion thereby causing retinal non-perfusion.

DR is the leading cause of preventable blindness and early detection and treatment is the only means of preventing it. Optical Coherence Tomography Angiography(OCTA) is a new imaging modality, which can detect these retinal microvascular changes at an early stage even before it’s clinical manifestation.

In our study we would quantify these changes in macular capillary vessel density in diabetic patients as compared to healthy population and also if any change is seen following specific DR treatment. And also  assess the  association between vessel density and visual acuity and that with levels of HbA1c and changes in the central retinal thickness.
 
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