Artifical Intelligence for automated detection of diabatic retinopathy from digital fundus images

Not Applicable

Completed

• Conditions: Health Condition 1: H578- Other specified disorders of eye and adnexa

• Registration Number: CTRI/2022/06/043402
• Lead Sponsor: Advenio tecnosys Private limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the Sensitivity and SpecificityTimepoint: At Baseline

Secondary Outcome Measures

Name	Time	Method
Adevin-i performance in discriminating Diabetic Retinopathy from rest of the Retinal AbnormalitiesTimepoint: At Baseline