| CTRI Number |
CTRI/2025/11/097568 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hemoglobin Levels and Diabetic Retinopathy Severity in Type 2 Diabetes: A Cross-Sectional Study |
|
Scientific Title of Study
|
Association between haemoglobin levels and the severity of diabetic retinopathy in patients with type 2 diabetes mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRIYANK SONANI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, Ground floor, AVBRH Building. Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8460807577 |
| Fax |
|
| Email |
priyank0707@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARCHANA THOOL |
| Designation |
PROFESSOR |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, Ground floor, AVBRH Building. Sawangi Meghe
Wardha
MAHARASHTRA
442002
India |
| Phone |
8097497803 |
| Fax |
|
| Email |
drarchana8030@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARCHANA THOOL |
| Designation |
PROFESSOR |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, Ground floor, AVBRH Building. Sawangi Meghe
Wardha
MAHARASHTRA
442002
India |
| Phone |
8097497803 |
| Fax |
|
| Email |
drarchana8030@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal nehru medical college, Sawangi(Meghe), Wardha, Maharashtra |
| Address |
Jawaharlal nehru medical college, Sawangi(Meghe), Wardha, Maharashtra 442001
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PRIYANK SONANI |
Acharya Vinobha Bhave Rural Hospital |
Department of Ophthalmology, Ground floor
AVBRH building, Sawangi Meghe
Wardha
MAHARASHTRA |
8460807577
priyank0707@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional ethics committee, Datta Meghe Institute of higher education & research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age
Male/Female
Patients having different stages of diabetes retinopathy
Patient having type 2 diabetes mellitus
Participants who have reduced levels of haemoglobin
Participants who gave the informed consent |
|
| ExclusionCriteria |
| Details |
Pregnant women
Patients with type 1 diabetes mellitus
Patients experiencing acute drops in hemoglobin levels due to bleeding
Patients with hemoglobinopathies.
Patients with malignancies.
Patients with other retinal pathologies
Patients with other systemic conditions affecting retina other than DM Type 2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between haemoglobin concentration (g/dL) and severity of diabetic retinopathy (DR) at baseline |
Single baseline assessment (at enrolment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/08/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The widespread metabolic disease known as type 2 diabetes mellitus (T2DM) is typified by both impaired insulin production and the incapacity of insulin-sensitive tissues to react to insulin as it should. One frequent microvascular condition that might lead to an avoidable cause of blindness is diabetic retinopathy (DR). To evaluate whether treatment methods should be modified, research is required to ascertain the prevalence of anaemia among diabetes patients. Anaemia has been linked to the development of DR and is a frequent complication in persons with type 2 diabetes. Aim of the study
To know the association between Hemoglobin levels and the severity of Diabetic Retinopathy in patients with type 2 Diabetes Mellitus
|