| CTRI Number |
CTRI/2025/09/094560 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Retinal Thickness And White Cell Inflammatory Biomarkers In Diabetic Retinopathy |
|
Scientific Title of Study
|
Retinal Thickness And White Cell Inflammatory Biomarkers In Diabetic Retinopathy - A Cross-Sectional Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Raihan |
| Designation |
Post Graduate |
| Affiliation |
Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute |
| Address |
Room no 118,First Floor, Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute Pondicherry Cuddalore EC Road, Pillaiyarkuppam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9744119859 |
| Fax |
|
| Email |
raihanmohammed007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A R Rajalakshmi |
| Designation |
Professor |
| Affiliation |
Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute |
| Address |
Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute Pondicherry Cuddalore EC Road, Pillaiyarkuppam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443332240 |
| Fax |
|
| Email |
ar_radha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A R Rajalakshmi |
| Designation |
Professor |
| Affiliation |
Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute |
| Address |
Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute Pondicherry Cuddalore EC Road, Pillaiyarkuppam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443332240 |
| Fax |
|
| Email |
ar_radha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute Pondicherry Cuddalore EC Road, Pillaiyarkuppam Pondicherry,India
607402 |
|
|
Primary Sponsor
|
| Name |
Depart Mahatma Gandhi Medical College and Research Institute |
| Address |
Room 118,First floor, Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute Pondicherry Cuddalore EC Road, Pillaiyarkuppam Pondicherry, India
607402 |
| 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 Mohammed Raihan |
Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute |
Room no 118,First Floor, Department Of Ophthalmology, Mahatma Gandhi Medical College and Research Institute Pondicherry Cuddalore EC Road, Pillaiyarkuppam Pondicherry
Pondicherry
PONDICHERRY
607402
India
Pondicherry
PONDICHERRY |
9744119859
raihanmohammed007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (Mahatma Gandhi Medical College and Research Institute) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
All willing patients with type 2 diabetes mellitus and willing to undergo OCT.
Age and gender match healthy individuals and willing to undergo OCT
|
|
| ExclusionCriteria |
| Details |
1. Patients with conditions which alter the WBC markers [auto immune or inflammatory disorders such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, malignancies (past or present), medications such as corticosteroids, immunosuppressant or anti-inflammatory medication and hematological disorder such as anemia, leukemias and platelet disorders].
2. Patients with recent history of intraocular surgeries or ocular trauma (within 3 months).
3. Patients with ocular and systemic diseases affecting retinal thickness like (hypertension, glaucoma, optic neuritis, high myopia).
4. Media opacities preventing OCT imaging (corneal opacity, corneal edema, cataract, vitreous hemorrhage).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To estimate and compare the levels of white cell inflammatory biomarkers and retinal thickness among diabetics with and without retinopathy and in non-diabetic healthy controls. |
This is a one time study. There is no follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
21/09/2025 |
| 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="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
|
There are few studies on retinal thickness and white blood cell inflammatory biomarker in diabetic retinopathy. The use of inflammatory biomarkers in diabetic retinopathy are also not much in use. If the use of inflammatory parameters for Diabetic Retinopathy is found to be effective and predictors, it will help in giving an early treatment and plan. |