| CTRI Number |
CTRI/2025/09/094456 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study To Observe Changes In Outer Surface of Eye And Tear Film In People With Type 2 Diabetes And Comparing It With Non-Diabetics |
|
Scientific Title of Study
|
Evaluation Of The Tear Film And Ocular Surface
Alterations 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 PARUL JAIN |
| Designation |
PROFESSOR |
| Affiliation |
GURU NANAK EYE CENTRE, MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF OPHTHALMOLOGY, MAULANA AZAD MEDICAL COLLEGE, GURU NANAK EYE CENTRE, NEW DELHI
Central
DELHI
110002
India |
| Phone |
9971927902 |
| Fax |
|
| Email |
pjain811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNIDHI RAUTHAN |
| Designation |
POST GRADUATE RESIDENT FIRST YEAR |
| Affiliation |
GURU NANAK EYE CENTRE, MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF OPHTHALMOLOGY, MAULANA AZAD MEDICAL COLLEGE, GURU NANAK EYE CENTRE, NEW DELHI
Central
DELHI
110002
India |
| Phone |
9013221582 |
| Fax |
|
| Email |
raygre612@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUNIDHI RAUTHAN |
| Designation |
POST GRADUATE RESIDENT FIRST YEAR |
| Affiliation |
GURU NANAK EYE CENTRE, MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF OPHTHALMOLOGY, MAULANA AZAD MEDICAL COLLEGE, GURU NANAK EYE CENTRE, NEW DELHI
Central
DELHI
110002
India |
| Phone |
9013221582 |
| Fax |
|
| Email |
raygre612@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF OPHTHALMOLOGY, GURU NANAK EYE CENTRE, MAULANA AZAD MEDICAL COLLEGE, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DELHI GATE, NEW DELHI,110002 |
| Type of Sponsor |
Government 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 SUNIDHI RAUTHAN |
GURU NANAK EYE CENTRE |
O.P.D., DEPARTMENT OF OPHTHALMOLOGY, GURU NANAK EYE CENTRE, MAULANA AZAD MEDICAL COLLEGE, NEW DELHI
Central
DELHI |
9013221582
raygre612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Group 1: Patients diagnosed with Diabetes Mellitus (Type II)
Group 2: Age and gender matched non-diabetics coming for routine checkup
2.18-50 years of age
|
|
| ExclusionCriteria |
| Details |
1.Patients with pre-existing autoimmune disorder.
2.Patients with renal failure.
3.Patients with ocular allergy.
4.Patients on any topical medication that may affect tear film.
5.Any ocular/ophthalmic surgery or trauma, which could affect corneal sensitivity and/or tear distribution within 6 months prior to screening.
6. Current or previous use of contact lens anticipated during the study or use 3 months prior to screening.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Impression Cytology score of both the groups. |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in QOL(OSDI) score, TBUT, Schirmer’s & OSS. |
BASELINE |
| Mean change in tear film biomarker (IL 6 levels). |
BASELINE |
| Correlation between ocular surface changes & the tear film biomarker. |
BASELINE |
| Mean change in Meiboscore using non-contact infrared meibography. |
BASELINE |
| Correlation of all ocular surface changes with duration & severity of diabetes (HbA1c levels). |
BASELINE |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/09/2025 |
| 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
|
This is a cross-sectional comparative study comparing tear film and ocular surface alterations between diabetics and non-diabetics. This study will be conducted in Guru Nanak Eye Centre. It will comprise of two groups with sample size of 20 per group. Primary outcome will be mean change in Impression Cytology score of both groups. Secondary outcome comprises of mean change in Ocular Surface Disease Index scare, TBUT, Schirmer’s score, Ocular surface Staining, tear film biomarker IL-6, Meiboscore, and correlation between ocular surface changes and the tear film biomarker. Also correlation of all ocular surface changes with duration and severity of diabetes. |