Artificial Intelligence for Staging Glaucoma Severity: A Comparison With an Eye Specialist Using Visual Field Tests (AI-GSS2)

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma and Ocular Hypertension
• Intervention / Treatment: Diagnostic test: Artificial Intelligence GSS2 Staging

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • Salerno, Italy, 84084
    • University of Salerno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Glaucoma Patients

Diagnostic test: Artificial Intelligence GSS2 Staging; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline (T0) and 1-year follow-up (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (T0) and 1-year follow-up (T1)

Collaborators and Investigators

• Sponsor: University of Salerno

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2011
• Primary Completion (Actual): July 24, 2025
• Study Completion (Actual): July 24, 2025

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: OftalmoUnisa2026_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No