Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Diacon Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age above or equal to 18 years 2. Documented type 1 or type 2 diabetes, LADA or other types of diabetes (per ADA criteria) 3. Above 18 years control group (with non diabetic)
Exclusion criteria
Exclusion criteria: 1. Recently treated DME with anti-VEGF or steroid therapy (previous 6 months) or lasered diabetic retinopathy (previous 6 months) 2. Other retinal pathology (AMD, RVO, etc.) 3. Active ocular infection or inflammation 4. Dry eye (Schirmer less than 15 mm) 5. Recent ocular surgery (less than 3 months) 6. Vitrectomy 7. GDM, pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Mean tear VEGF concentration (pg/mL) in the study population 2. Correlation between tear VEGF and DR severityTimepoint: baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess tear TNF alpha & IL6 levels alongside VEGF as a multi-biomarker panel. 2. To determine diagnostic accuracy (sensitivity, specificity, AUC) of tear VEGF for detecting any DR & sight threatening DR. 3. To identify optimal tear VEGF cutoff values for DR screening. 4. To correlate tear VEGF with clinical parameters (HbA1c, diabetes duration, blood pressure, lipid profile). 5. To correlate tear VEGF with OCT findings (central subfield thickness, fluid volume) in DME patients. Timepoint: baseline | — |
Countries
India
Contacts
Public ContactDr Bhavana Sosale
Diacon Hospital
Outcome results
None listed