| CTRI Number |
CTRI/2026/01/101469 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship Between Eye Surface Health and Nerve Problems in People with Type 2 Diabets |
|
Scientific Title of Study
|
Correlating Peripheral Neuropathy Symptoms with Ocular Surface Parameters in Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran |
| Designation |
Optometrist |
| Affiliation |
Centre For Sight Eye Hospital |
| Address |
Centre For Sight Eye Hospital, Plot No 9,Ophthalmology Department, Optom Room No 1, Diagnostic 1, Dwarka Sector 9, Dwarka, New Delhi - 110077
Centre For Sight Eye Hospital, Plot No 9,Ophthalmology Department, Optom Room No 1, Diagnostic 1, Dwarka Sector 9, Dwarka, New Delhi - 110077
West
DELHI
110077
India |
| Phone |
7838871921 |
| Fax |
|
| Email |
sgalhotra71.sg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Roshani Sen Gupta |
| Designation |
Assistant Professor |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka Educational City, Sohna-Gurgon Rd,Sohna,Sohna Rural, Haryana 122103
GD Goenka Educational City, Sohna-Gurgon Rd,Sohna,Sohna Rural, Haryana 122103
Gurgaon
HARYANA
122103
India |
| Phone |
7980632247 |
| Fax |
|
| Email |
roshani.sengupta@gdgu.org |
|
Details of Contact Person
Public Query
|
| Name |
Simran |
| Designation |
Optometrist |
| Affiliation |
Centre For Sight Eye Hospital |
| Address |
Centre For Sight Eye Hospital, Plot No 9,Ophthalmology Department, Optom Room No 1, Diagnostic 1, Dwarka Sector 9, Dwarka, New Delhi
Centre For Sight Eye Hospital, Plot No 9,Ophthalmology Department, Optom Room No 1, Diagnostic 1, Dwarka Sector 9, Dwarka, New Delhi
New Delhi
DELHI
110077
India |
| Phone |
7838871921 |
| Fax |
|
| Email |
sgalhotra71.sg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre For Sight Eye Hospital, Plot No 9,Ophthalmology Department, Optom Room No 1, Diagnostic 1, Dwarka Sector 9, Dwarka, New Delhi, Delhi -110077 , Provided infrastructure and routine clinical facilities |
|
|
Primary Sponsor
|
| Name |
Centre For Sight Eye Hospital |
| Address |
Plot no 9, Dwarka sector 9, Dwarka , New Delhi 110077 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Simran |
Centre For Sight Eye Hospital |
Centre For Sight Eye Hospital, Plot No 9,Ophthalmology Department, Optom Room No 1, Diagnostic 1, Dwarka Sector 9, Dwarka, New Delhi - 110077
West
DELHI |
07838871921
sgalhotra71.sg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre For Sight Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes Mellitus Type 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
adults aged 30 to 70 years clinically diagnosed cases of type 2 diabetes mellitus
duration of diabetes greater than or equal to 1 year
patients attending the outpatient department who are clinically stable at the time of examination
willingness to participate and provide written informed consent
ability to undergo
michigan neuropathy screening instrument
ocular surface disease index questionnaire
tear function testing and non invasive ocular surface analyzer evaluation
|
|
| ExclusionCriteria |
| Details |
History of ocular surgery, laser procedures, or significant ocular trauma
Current contact lens wearers
Presence of active ocular infection or inflammation
Diagnosed autoimmune or connective tissue disorders known to affect the ocular surface
Systemic neurological conditions or neuropathies other than diabetic neuropathy
Use of topical ocular medications (other than preservative-free lubricants)
Patients with ocular pathology that may confound ocular surface assessment
Pregnant or lactating women
Individuals unable to cooperate with study procedures or questionnaires |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation Between Peripheral Neuropathy Severity, Assessed Using MNSI Score And Ocular Surface Disease severity, Assessed Using OSDI Score, Schirmer’s Test Values, And Ocular Surface Analyzer Parameters in Patients With Type 2 Diabetes Mellitus. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison Of Ocular Surface Parameters Between Diabetic Patients With And Without Peripheral Neuropathy.
Assessment Of Symptom–sign Dissociation Between OSDI Scores And Objective Ocular Surface Measurements.
Evaluation Of The Relationship Between Duration Of Diabetes And Ocular Surface Changes.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
01/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
After obtaining written informed
consent, participants will be evaluated in the following standardized sequence
Screening for dry eye disease
through Schirmer’s test in clinical evaluation.
Assessment of peripheral neuropathy
using the Michigan
Neuropathy Screening Instrument (MNSI) questionnaire
Objective evaluation of ocular
surface parameters using an Ocular Surface Analyzer (OSA)
Assessment of dry eye symptoms
using the Ocular
Surface Disease Index (OSDI) questionnaire
All assessments will be performed
by a trained examiner to ensure uniformity and minimize bias.
|