Health Condition 1: H578- Other specified disorders of eye and adnexa
Conditions
Interventions
None listed
Sponsors
Advenio tecnosys Private limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age >= 18 2.Male/female 3.Persons diagnosed with diabetes and prior to the current study have not been diagnosed with Diabetic Retinopathy (DR). 4.Hemoglobin A1c (HbA1c >= 6.5% based on repeated assessments 5.Fasting Plasma Glucose (FPG) >= 126 mg/dL (7.0 mmol/L) based on repeated assessments Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) >= 200mg/dL (11.1 mmol/L) using the equivalent of an oral 75g anhydrous glucose dose dissolved in water. 6.Symptoms of hyperglycemia or hyper glycemic crisis with a random plasma glucose (RPG)>= 200 mg/dL (11.1 mmol/L) 7.Subjects willing to give written informed consent and come for a regular follow up.
Exclusion criteria
Exclusion criteria: Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters. • History of laser treatment of the retina or injections into either eye, or any history of retinal surgery. • Currently participating in another investigational eye study and actively receiving investigational product for DR or DME. • Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation). • Participant is contraindicated for imaging by fundus imaging systems used in the study: • Participant is hypersensitive to light • Participant recently underwent photodynamic therapy (PDT) • Participant is taking medication that causes photosensitivity • Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Sensitivity and SpecificityTimepoint: At Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Adevin-i performance in discriminating Diabetic Retinopathy from rest of the Retinal AbnormalitiesTimepoint: At Baseline | — |
Countries
India
Contacts
Public ContactDr K chandra Mohan
Moden Retinal center
Outcome results
None listed