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Smartphone based Fundus Camera for Glaucoma Screening

Evaluation of an automated system for glaucoma screening that runs offline on a smartphone-based fundus camera

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/01/049033
Enrollment
200
Registered
2023-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: H401- Open-angle glaucoma

Interventions

None listed

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants who can provide a written informed consent

Exclusion criteria

Exclusion criteria: 1.Subject with unreliable visual fields (Defined as >20% rate of fixation losses and >15% false-positive and false-negative results.) 2.Subject with SD-OCT signal strength 3.Subject deemed to have narrow angles on gonioscopy and cannot be dilated without a laser iridotomy (PI) 4.Participants unwilling to sign the informed consent 5.Subject with acute or sudden vision loss 6.Other causes of optic neuropathy 7.Co-existing retinal/disc pathologies that does not allow reliable assessment of disc like vitreous hemorrhage, congenital disc abnormalities, advanced retinopathy of prematurity etc 8.Significant media opacity precluding adequate view of the disc like advanced cataract as described below, corneal scars 9.Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., uncontrolled intraocular pressure, active eye infection, 10.Participant is hypersensitive to light, known to have seizures, consuming medication that causes photosensitivity.

Design outcomes

Secondary

MeasureTime frame
1.Assess the sensitivity of the tool of the AI tool to detect various stages of glaucoma 2.Assess the precision of the tool 3.Compare diagnostic ability (sensitivity and specificity) of AI alone versus AI used in combination with IOP measurement Timepoint: Review after 12 months

Primary

MeasureTime frame
Assess the diagnostic ability in terms of sensitivity and specificity of an automated glaucoma screening tool to detect referable glaucoma (certain glaucoma) against the diagnosis made by glaucoma specialistTimepoint: Review after 12 months

Countries

India

Contacts

Public ContactDrSirisha Senthil

L V Prasad Eye Institute

sirishasenthil@lvpei.org04068102619

Outcome results

None listed

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