Glaucoma and Ocular HypertensionAI-GSS2NCT07820709
Artificial Intelligence for Staging Glaucoma Severity: A Comparison With an Eye Specialist Using Visual Field Tests
An observational study of Glaucoma and Ocular Hypertension, run by University of Salerno at 1 site in Italy.
Trial summary
The study titled "Reliability of Artificial Intelligence in Glaucoma Severity Staging Using the Brusini GSS2 System: A Longitudinal Comparative Study against Expert Assessment" aims to evaluate the diagnostic reliability and clinical utility of an Artificial Intelligence (AI) system in staging glaucoma severity using… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma and Ocular Hypertension
- What is being tested?
- Artificial Intelligence GSS2 Staging
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2011to 24 Jul 2025
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Adult patients with glaucoma or suspected glaucoma attending the Ophthalmology Unit of University of Salerno for routine glaucoma follow-up. Eligible participants underwent standard automated visual field testing at baseline and approximately 1-year follow-up. Visual fields were independently staged by an artificial intelligence system and an expert ophthalmologist using the Brusini Glaucoma Staging System 2 (GSS2).
Who may be able to join
- Adults (≥18 years of age).
- Diagnosis of glaucoma or suspected glaucoma undergoing routine clinical follow-up.
- Availability of reliable standard automated visual field (VF) examinations at baseline and approximately 1-year follow-up.
- Visual field tests suitable for staging using the Brusini Glaucoma Staging System 2 (GSS2).
- Availability of all clinical data required for study analysis.
Who cannot join
- Unreliable visual field examinations (e.g., excessive fixation losses, false-positive or false-negative responses according to institutional reliability criteria).
- Visual field defects attributable to ocular or neurological diseases other than glaucoma.
- Missing baseline or follow-up visual field examinations.
- Incomplete clinical data preventing GSS2 staging or statistical analysis.
- Previous ocular conditions or interventions that could significantly affect visual field interpretation, if judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Artificial Intelligence in Glaucoma Severity Staging Using the Brusini GSS2 System: A Longitudinal Comparative Study Against Expert Assessment
The study titled "Reliability of Artificial Intelligence in Glaucoma Severity Staging Using the Brusini GSS2 System: A Longitudinal Comparative Study against Expert Assessment" aims to evaluate the diagnostic reliability and clinical utility of an Artificial Intelligence (AI) system in staging glaucoma severity using the Brusini Glaucoma Staging System 2 (GSS2) compared to expert ophthalmologist assessment.
The study protocol involves the longitudinal analysis of visual fields (VFs) collected at baseline (T0) and at a 1-year follow-up (T1). Statistical methodology will utilize quadratic weighted Cohen's kappa to assess diagnostic agreement between the AI system and expert assessment, Wilcoxon signed-rank tests to evaluate potential systematic bias, and Spearman's rank correlation to investigate the relationship between longitudinal progression and changes in the clinical Visual Field Index.
- Conditions
- Glaucoma and Ocular Hypertension
- Being tested
- Artificial Intelligence GSS2 Staging
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence GSS2 StagingDiagnostic test
An artificial intelligence system used to automatically stage glaucoma severity from standard automated visual field tests according to the Brusini Glaucoma Staging System 2 (GSS2). AI classifications were compared with those of an expert ophthalmologist at baseline and 1-year follow-up. The AI was used for assessment only and did not influence patient management or treatment.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Patients | Not described Receives: Diagnostic Test: Artificial Intelligence GSS2 Staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadratic weighted Cohen's kappa coefficient for diagnostic agreement in glaucoma severity staging between AI and expert assessment
Glaucoma severity will be staged (from Stage 0 to Stage 5) using the Brusini Glaucoma Staging System 2 (GSS2) based on visual field parameters. Staging will be performed independently by the AI system and an expert ophthalmologist at each time point. Inter-rater agreement between the AI and expert staging will be quantified using the quadratic weighted Cohen's kappa ($\kappa$), where values range from -1 (complete disagreement) to +1 (perfect agreement).
Measured: Baseline (T0) and 1-year follow-up (T1)
Secondary outcomes (1)
Median difference in Brusini GSS2 staging scores between AI and expert assessment
Differences in Brusini Glaucoma Staging System 2 (GSS2) staging scores (ranging from Stage 0 to Stage 5) assigned by the AI system versus the expert ophthalmologist will be evaluated to detect systematic overestimation or underestimation of disease severity. Paired score differences (AI minus Expert) at each time point will be reported and statistically tested using the Wilcoxon signed-rank test.
Measured: Baseline (T0) and 1-year follow-up (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start15 Apr 2011
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma and Ocular HypertensionStudies 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maddalena DE BERNARDO, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820709
- Sponsor's protocol ID
- OftalmoUnisa2026_1
- Acronym
- AI-GSS2
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Artificial Intelligence in Glaucoma Severity Staging Using the Brusini GSS2 System: A Longitudinal Comparative Study Against Expert Assessment
- ClinicalTrials.gov ID
- NCT07820709
- Acronym / sponsor ID
- AI-GSS2 / OftalmoUnisa2026_1
- Conditions
- Glaucoma and Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 15 Apr 2011 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 15 Sep 2026 (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.
The study titled "Reliability of Artificial Intelligence in Glaucoma Severity Staging Using the Brusini GSS2 System: A Longitudinal Comparative Study against Expert Assessment" aims to evaluate the diagnostic reliability and clinical utility of an Artificial Intelligence (AI) system in staging glaucoma severity using the Brusini Glaucoma Staging System 2 (GSS2) compared to expert ophthalmologist assessment.
The study protocol involves the longitudinal analysis of visual fields (VFs) collected at baseline (T0) and at a 1-year follow-up (T1). Statistical methodology will utilize quadratic weighted Cohen's kappa to assess diagnostic agreement between the AI system and expert assessment, Wilcoxon signed-rank tests to evaluate potential systematic bias, and Spearman's rank correlation to investigate the relationship between longitudinal progression and changes in the clinical Visual Field Index.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Patients | – | Diagnostic Test: Artificial Intelligence GSS2 Staging |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with glaucoma or suspected glaucoma attending the Ophthalmology Unit of University of Salerno for routine glaucoma follow-up. Eligible participants underwent standard automated visual field testing at baseline and approximately 1-year follow-up. Visual fields were independently staged by an artificial intelligence system and an expert ophthalmologist using the Brusini Glaucoma Staging System 2 (GSS2).
Key inclusion criteria (5 listed)
- Adults (≥18 years of age).
- Diagnosis of glaucoma or suspected glaucoma undergoing routine clinical follow-up.
- Availability of reliable standard automated visual field (VF) examinations at baseline and approximately 1-year follow-up.
- Visual field tests suitable for staging using the Brusini Glaucoma Staging System 2 (GSS2).
- Availability of all clinical data required for study analysis.
Key exclusion criteria (5 listed)
- Unreliable visual field examinations (e.g., excessive fixation losses, false-positive or false-negative responses according to institutional reliability criteria).
- Visual field defects attributable to ocular or neurological diseases other than glaucoma.
- Missing baseline or follow-up visual field examinations.
- Incomplete clinical data preventing GSS2 staging or statistical analysis.
- Previous ocular conditions or interventions that could significantly affect visual field interpretation, if judged by the investigator.
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 |
|---|---|---|
| Artificial Intelligence GSS2 StagingAn artificial intelligence system used to automatically stage glaucoma severity from standard automated visual field tests according to the Brusini Glaucoma Staging System 2 (GSS2). AI classifications were compared with those of an expert ophthalmologist at baseline and 1-year follow-up. The AI was used for assessment only and did not influence patient management or treatment. | Diagnostic test | Glaucoma Patients |
Primary outcome
Quadratic weighted Cohen's kappa coefficient for diagnostic agreement in glaucoma severity staging between AI and expert assessment
Time frame: Baseline (T0) and 1-year follow-up (T1)
Glaucoma severity will be staged (from Stage 0 to Stage 5) using the Brusini Glaucoma Staging System 2 (GSS2) based on visual field parameters. Staging will be performed independently by the AI system and an expert ophthalmologist at each time point. Inter-rater agreement between the AI and expert staging will be quantified using the quadratic weighted Cohen's kappa ($\kappa$), where values range from -1 (complete disagreement) to +1 (perfect agreement).
1 secondary outcome
Median difference in Brusini GSS2 staging scores between AI and expert assessment
Time frame: Baseline (T0) and 1-year follow-up (T1)
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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 and Ocular Hypertension, run by University of Salerno at 1 site in Italy.
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 5 inclusion and 5 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 15 Sep 2026. 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 Italy. 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?
Quadratic weighted Cohen's kappa coefficient for diagnostic agreement in glaucoma severity staging between AI and expert assessment (time frame: Baseline (T0) and 1-year follow-up (T1)). 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 15 Sep 2026.