Reliability of Artificial Intelligence in Glaucoma Severity Staging Using the Brusini GSS2 System: A Longitudinal Comparative Study Against Expert Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quadratic weighted Cohen's kappa coefficient for diagnostic agreement in glaucoma severity staging between AI and expert assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Glaucoma Patients
干预措施: Artificial Intelligence GSS2 Staging (Diagnostic Test)
结局指标
主要结局
Quadratic weighted Cohen's kappa coefficient for diagnostic agreement in glaucoma severity staging between AI and expert assessment
时间窗: 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).
次要结局
- Median difference in Brusini GSS2 staging scores between AI and expert assessment(Baseline (T0) and 1-year follow-up (T1))
研究者
Maddalena DE BERNARDO
Professor
University of Salerno