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Validation of Medios AI, an Automated Artificial intelligence Glaucoma Screening Tool, on a Smartphone Based Fundus Camera in real world setting

Validation of Medios AI, an Automated Glaucoma Screening Tool, Deployed Offline, On-The-Edge, on a Smartphone Based Fundus Camera- a prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/035145
Enrollment
200
Registered
2021-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H406- Glaucoma secondary to drugs Health Condition 2: H403- Glaucoma secondary to eye trauma Health Condition 3: H405- Glaucoma secondary to other eye disorders Health Condition 4: H400- Glaucoma suspect Health Condition 5: H401- Open-angle glaucoma Health Condition 6: H402- Primary angle-closure glaucoma

Interventions

Control Intervention1: Nil: Nil

Sponsors

Remidio Innovative Solutions Pvt Ltd
Lead Sponsor
Aravind Eye Hospital Pondicherry
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Glaucoma Group:Any case of glaucoma with typical glaucomatous disc changes, confirmed by clinical evaluation and visual field test (primary open angle glaucoma(POAG), normal tension glaucoma (NTG), primary angle closure glaucoma (PACG), secondary glaucomas) 2.Normal Controls (including Ocular hypertension (OHT) and primary angle closure suspects (PACS) status post laser peripheral iridotomy (LPI)) 3.Disc suspects 4.Reliable Visual field (false positive (FP), false negative (FN)

Exclusion criteria

Exclusion criteria: 1.Patient with acute or sudden vision loss 2.Patient deemed to have narrow angles on gonioscopy and cannot be dilated (primary angle closure) 3.Co-existing retinal pathologies precluding view of disc including Proliferative diabetic retinopathy 4.Significant media opacity precluding adequate view of the disc 5. 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, 6.Participant is contraindicated for imaging by fundus imaging systems used in the study: a.Participant is hypersensitive to light b.Participant recently underwent photodynamic therapy (PDT) c.Participant is photosensitive or is consuming medication that causes photosensitivity.

Design outcomes

Primary

MeasureTime frame
Assess the sensitivity and specificity of the Medios AI in detecting referable glaucoma when compared to reference standard of glaucoma diagnosis made by glaucoma specialist following a complete evaluation.Timepoint: Baseline

Secondary

MeasureTime frame
1)Assess the positive predictive value, negative predictive value of Medios AI for detecting referable glaucoma. 2)Assess the sensitivity of the Medios AI in detecting certain glaucoma. 3)Assess the accuracy of the automated vertical cup to disc ratio (VCDR) algorithm to that of the specialist during a stereoscopic clinical exam. 4)Agreement between automated VCDR, clinical stereoscopic disc exam and spectral domain optical coherence tomography (SD-OCT) Timepoint: 2 months

Countries

India

Contacts

Public ContactDr Swati Upadhyaya

Aravind Eye Hospital

swati.dr@aravind.org8489810704

Outcome results

None listed

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