Glaucoma Clinical Trial
Official title:
Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | IOBA - Universidad de Valladolid | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and Specificity of an automated classification system for retinographies | Day 0 |
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