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

I

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

Status

Completed

Conditions

Glaucoma
Ocular Hypertension
Glaucoma, Suspect

Treatments

Diagnostic Test: Fundus Photographs (retinographies)

Study type

Observational

Funder types

Other

Identifiers

NCT04972695
PI 21-2278

Details and patient eligibility

About

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.

Enrollment

615 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

615 participants in 2 patient groups

Glaucoma
Description:
People with diagnosis of Primary Open Angle Glaucoma (POAG)
Treatment:
Diagnostic Test: Fundus Photographs (retinographies)
Ocular Hypertension / glaucoma suspect
Description:
People with diagnosis of Ocular Hypertension or POAG suspicion
Treatment:
Diagnostic Test: Fundus Photographs (retinographies)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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