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NCT04972695 Clinical Trial

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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04972695
Other study ID # PI 21-2278
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 7, 2021
Est. completion date February 23, 2022

Study information
Verified date February 2022
Source Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 615
Est. completion date February 23, 2022
Est. primary completion date February 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Fundus Photographs (retinographies)
Fundus photographs under mydriasis

Locations
Country Name City State
Spain IOBA - Universidad de Valladolid Valladolid

Sponsors (1)
Lead Sponsor Collaborator
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity of an automated classification system for retinographies Day 0
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