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

February 25, 2022 updated by: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

615

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47011
        • IOBA - Universidad de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ocular hypertensive patients or patients with diagnosis of Glaucoma.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and Specificity of an automated classification system for retinographies
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Actual)

February 23, 2022

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 21-2278

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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