Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images

NCT04972695 | Completed

• 1 other identifier: PI 21-2278
• Study Type: observational
• Target: 615
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical, cross-sectional and prospective study to assess the images of the posterior pole of the retina of patients from the Glaucoma Unit of the IOBA and the Hospital Clínico Universitario de Valladolid during the period between May and December 2021. The aim of the project is to provide a sufficient number of images from posterior pole retinographies in patients with suspected glaucoma or with diagnosis of glaucoma in order to determine the sensitivity and specificity of an automatic glaucoma screening algorithm developed by the company Transmural Biotech S.L.

Conditions

Glaucoma, Suspect; Glaucoma; Ocular Hypertension

Keywords

Deep Learning; Diagnoses Disease; Glaucoma; retinographies

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of an automated classification system for retinographies

  Day 0

Study Arms (2)

Glaucoma

People with diagnosis of Primary Open Angle Glaucoma (POAG)

Diagnostic Test: Fundus Photographs (retinographies)

Ocular Hypertension / glaucoma suspect

People with diagnosis of Ocular Hypertension or POAG suspicion

Diagnostic Test: Fundus Photographs (retinographies)

Interventions

Fundus Photographs (retinographies) DIAGNOSTIC_TEST

Fundus photographs under mydriasis

Glaucoma; Ocular Hypertension / glaucoma suspect

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ocular hypertensive patients or patients with diagnosis of Glaucoma.

You may qualify if:

• Primary open angle glaucoma or ocular hypertension
• Signed informed consent
• Visual field examination within the last 12 months

You may not qualify if:

• Ocular or systemic pathologies that may interfere with the quality of the retinographic image or the results of the visual field
• Congenital anomalies of the papilla that seriously alter its structure
• High ametropia (\> 10 diopters)
• Pharmacological Mydriasis contraindication.

Sponsors & Collaborators

• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: lead

Study Sites (1)

IOBA - Universidad de Valladolid

Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: May 7, 2021
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

ES (1)