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

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.

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Key information

Conditions

Glaucoma, Suspect Eye Diseases Glaucoma Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IOBA - Universidad de Valladolid

Valladolid, 47011, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Fundus Photographs (retinographies)

Diagnostic Test

Fundus photographs under mydriasis

Primary outcomes

Sensitivity and Specificity of an automated classification system for retinographies

Time frame: Day 0

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 22, 2021
Registry last updated: Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed