NCT07820709Completed
Artificial Intelligence for Staging Glaucoma Severity: A Comparison With an Eye Specialist Using Visual Field Tests
Reliability of Artificial Intelligence in Glaucoma Severity Staging Using the Brusini GSS2 System: A Longitudinal Comparative Study Against Expert Assessment
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 14 Jul 2026
- Start date
- 15 Apr 2011
- Primary completion date
- 24 Jul 2025
- Lead sponsor
- University of Salerno
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT07820709
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 15 Apr 2011 to the primary completion date, 24 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ocular conditions or interventions that could significantly affect visual field interpretation, if judged by the investigator.
Other illness
- Visual field defects attributable to ocular or neurological diseases other than glaucoma.
Other
- Unreliable visual field examinations (e.g., excessive fixation losses, false-positive or false-negative responses according to institutional reliability criteria).
- Missing baseline or follow-up visual field examinations.
- Incomplete clinical data preventing GSS2 staging or statistical analysis.
Who the study is looking for
- 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.
Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Salerno Coordinator of this site? Confirm its status | Salerno | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.