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Evaluation of retinal images taken for the participants and Diabetic Retinopathy AI performance among the new automated non-mydriatic fundus camera and standard fundus camera

Evaluation of Retinal Image Quality, Lesion Detection and Diabetic Retinopathy AI Performance Using a New Automated Non-Mydriatic Tabletop Fundus Camera: A Prospective Validation Against a Reference Standard System - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099471
Enrollment
600
Registered
2025-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: H350- Background retinopathy and retinalvascular changes

Interventions

Intervention1: Nil: Nil

Sponsors

Remidio Innovative Solutions Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All subjects above 18 years of age and ready to give written consent

Exclusion criteria

Exclusion criteria: 1. significant media opacities (e.g., advanced cataract, corneal opacity) 2. inability to fixate (e.g., nystagmus, amblyopia) 3. active ocular infection or post-operative status 4. hypersensitivity to light, or contraindications to pharmacological dilation (e.g., angle-closure glaucoma)

Design outcomes

Primary

MeasureTime frame
Proportion of gradable vs. ungradable images per device Level of agreement in image quality between devices AI performance metrics per device Agreement or discordance in DR detection between devices InstaZ performance in retinal lesion detection Agreement in gradability pre- vs. post-dilation Repeatability of InstaZ image outputs Timepoint: Baseline

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Manavi D Sindal

Aravind Eye Hospital

manavi@aravind.org09884081417

Outcome results

None listed

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