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

NCT ID: NCT04972695

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

615 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-07

Study Completion Date

2022-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma, Suspect Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Glaucoma

People with diagnosis of Primary Open Angle Glaucoma (POAG)

Fundus Photographs (retinographies)

Intervention Type DIAGNOSTIC_TEST

Fundus photographs under mydriasis

Ocular Hypertension / glaucoma suspect

People with diagnosis of Ocular Hypertension or POAG suspicion

Fundus Photographs (retinographies)

Intervention Type DIAGNOSTIC_TEST

Fundus photographs under mydriasis

Interventions

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Fundus Photographs (retinographies)

Fundus photographs under mydriasis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IOBA - Universidad de Valladolid

Valladolid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI 21-2278

Identifier Type: -

Identifier Source: org_study_id

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