Health Condition 1: E103- Type 1 diabetes mellitus with ophthalmic complications Health Condition 2: E109- Type 1 diabetes mellitus without complications Health Condition 3: E113- Type 2 diabetes mellitus with ophthalmic complications Health Condition 4: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Intervention5: Nil: Nil
Intervention6: Nil: Nil
Intervention7: Nil: Nil
Sponsors
Manipal Academy of Higher Education Manipal
Eligibility
Inclusion criteria
Inclusion criteria: Group 1: Non- Diabetic Individuals 1. Age 18 years and above 2. Patients/ Participants with no history of diabetes or diabetic retinopathy or other systemic or ocular diseases affecting microvasculature Group 2: Diabetes Mellitus without retinopathy 1. Age 18 years and above 2. Patients/Participants with diabetes (Type 1 or Type 2) 3. No history of clinical evidence of diabetic retinopathy Group 3: Diabetic Retinopathy 1. Age 18 years and above 2. Patients/Participants with diabetic retinopathy
Exclusion criteria
Exclusion criteria: History of 1. presence of other retinal diseases (Age Related Macular Degeneration, Retinal Vein Occlusion, Center involving macular edema (edema involving the central 1 mm zone (fovea)) 2. ocular surgery within the past 6 months 3. Media opacities severe enough to affect fundus imaging 4. Gestational Diabetes, Pregnant or lactating women 5. Diabetic Nephropathy (stage 4 and 5), based on the available data on estimated glomerular filtration rate (eGFR) 6. Any injury to finger or finger trauma in last 2 weeks 7. systemic lupus erythematosus (SLE) evaluated or determined by ANA global immunofluorescence test or already diagnosed 8. Conditions affecting nailfold capillaries autoimmune disorders (Scleroderma) and connective tissue disorders 9. Presence of nail conditions or deformities that obscure nailfold capillary examination (severe nail dystrophy, onychomycosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the correlation between the changes observed in the nailfold capillaries and the retinal microvasculature in non-diabetic controls, Diabetes Mellitus with and without RetinopathyTimepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To grade the nailfold capillary changes across different stages of diabetic retinopathyTimepoint: 24 months;To identify potential predictive markers in the nailfold capillaries that may indicate early microvascular changes in the retina for early diagnosis of Diabetic RetinopathyTimepoint: 24 months;To assess the clinical utility of Optical Coherence Tomography-Angiography (OCT-A) in identifying early retinal microvascular changes and its correlation with systemic microvascular alterations detected by nailfold imaging device in diabetic retinopathy patientsTimepoint: 24 months | — |
Countries
India
Contacts
Public ContactDr Yogish S Kamath
Kasturba Medical College Manipal MAHE Manipal
Outcome results
None listed