Glaucoma, SuspectNCT04972695
Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images
An observational study of Glaucoma, Suspect and Glaucoma, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Suspect, Glaucoma, Ocular Hypertension
- What is being tested?
- Fundus Photographs (retinographies)
- How many people
- 615 participants
- Where
- 1 siteSpain
- Study dates
- 7 May 2021to 23 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ocular hypertensive patients or patients with diagnosis of Glaucoma.
Who may be able to join
- Primary open angle glaucoma or ocular hypertension
- Signed informed consent
- Visual field examination within the last 12 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glaucoma, Suspect, Glaucoma, Ocular Hypertension
- Being tested
- Fundus Photographs (retinographies)
- Keywords
- Deep Learning, Diagnoses Disease, Glaucoma, retinographies
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus Photographs (retinographies)Diagnostic test
Fundus photographs under mydriasis
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | People with diagnosis of Primary Open Angle Glaucoma (POAG) Receives: Diagnostic Test: Fundus Photographs (retinographies) | |
| Ocular Hypertension / glaucoma suspect | People with diagnosis of Ocular Hypertension or POAG suspicion Receives: Diagnostic Test: Fundus Photographs (retinographies) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of an automated classification system for retinographies
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start7 May 2021
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, SuspectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972695
- Sponsor's protocol ID
- PI 21-2278
- Status last verified
- Feb 2022
- First submitted
- 12 Jul 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images
- ClinicalTrials.gov ID
- NCT04972695
- Acronym / sponsor ID
- PI 21-2278
- Conditions
- Glaucoma, Suspect, Glaucoma, Ocular Hypertension
- Keywords
- Deep Learning, Diagnoses Disease, Glaucoma, retinographies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | Diagnostic Test: Fundus Photographs (retinographies)People with diagnosis of Primary Open Angle Glaucoma (POAG) |
| Ocular Hypertension / glaucoma suspect | – | Diagnostic Test: Fundus Photographs (retinographies)People with diagnosis of Ocular Hypertension or POAG suspicion |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ocular hypertensive patients or patients with diagnosis of Glaucoma.
Key inclusion criteria (3 listed)
- Primary open angle glaucoma or ocular hypertension
- Signed informed consent
- Visual field examination within the last 12 months
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fundus Photographs (retinographies)Fundus photographs under mydriasis | Diagnostic test | Glaucoma, Ocular Hypertension / glaucoma suspect |
Primary outcome
Sensitivity and Specificity of an automated classification system for retinographies
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Suspect and Glaucoma, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of an automated classification system for retinographies (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.