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

• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (Other)
• Overall Status: Completed
• CT.gov ID: NCT04972695
• Collaborator: (none)
• Enrollment: 615
• Location: 1
• Actual Duration (Months): 9.6
• Patients Per Site Per Month: 64.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Suspect; Glaucoma; Ocular Hypertension	Diagnostic Test: Fundus Photographs (retinographies)

Study Design

• Study Type: Observational
• Actual Enrollment: 615 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images
• Actual Study Start Date: May 7, 2021
• Actual Primary Completion Date: Feb 23, 2022
• Actual Study Completion Date: Feb 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Glaucoma People with diagnosis of Primary Open Angle Glaucoma (POAG)	Diagnostic Test: Fundus Photographs (retinographies); Fundus photographs under mydriasis
Ocular Hypertension / glaucoma suspect People with diagnosis of Ocular Hypertension or POAG suspicion	Diagnostic Test: Fundus Photographs (retinographies); Fundus photographs under mydriasis

Outcome Measures

Primary Outcome Measures

1. Sensitivity and Specificity of an automated classification system for retinographies [Day 0]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IOBA - Universidad de Valladolid	Valladolid		Spain	47011

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• ClinicalTrials.gov Identifier: NCT04972695
• Other Study ID Numbers: PI 21-2278
• First Posted: Jul 22, 2021
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: Deep Learning; Diagnoses Disease; Glaucoma; retinographies
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension

Study Results

No Results Posted as of Feb 28, 2022