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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

Evaluation Of The Tear Film And Ocular Surface Alterations In Patients With Type 2 Diabetes Mellitus - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/094456
Enrollment
40
Registered
2025-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Nil: Nil

Sponsors

MAULANA AZAD MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Mean change in Impression Cytology score of both the groups.Timepoint: BASELINE

Secondary

MeasureTime frame
Mean change in QOL(OSDI) score, TBUT, Schirmer?s & OSS.Timepoint: BASELINE;Mean change in tear film biomarker (IL 6 levels).Timepoint: BASELINE;Correlation between ocular surface changes & the tear film biomarker.Timepoint: BASELINE;Mean change in Meiboscore using non-contact infrared meibography.Timepoint: BASELINE;Correlation of all ocular surface changes with duration & severity of diabetes (HbA1c levels).Timepoint: BASELINE

Countries

India

Contacts

Public ContactDR SUNIDHI RAUTHAN

GURU NANAK EYE CENTRE, MAULANA AZAD MEDICAL COLLEGE

raygre612@gmail.com9013221582

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026