Glaucoma Screening With Artificial Intelligence - A Randomized Clinical Trial Comparing Retinal Nerve Fiber Layer Optical Texture Analysis and Optic Disc Photography Assessment
试验速览
- 阶段
- 不适用
- 入组人数
- 3,175
- 试验地点
- 2
- 主要终点
- Diagnostic performance for detection of glaucoma
研究概览
简要总结
This randomized clinical trial aims to compare the diagnostic performance of two AI-enabled screening strategies - ROTA (RNFL optical texture analysis) assessment versus optic disc photography - in detecting glaucoma within a population-based sample. Secondary objectives are to (1) compare the diagnostic performance of ROTA AI assessment versus OCT RNFL thickness assessment by AI, and ROTA AI assessment versus OCT RNFL thickness assessment by trained graders, (2) investigate the cost-effectiveness of AI ROTA assessment for glaucoma screening, and (3) estimate the prevalence of glaucoma in Hong Kong.
详细描述
Glaucoma is the leading cause of irreversible blindness affecting 76 million patients worldwide in 2020. Characterized by progressive degeneration of the optic nerve, early detection of disease deterioration with timely intervention is critical to prevent progressive loss in vision. In the 5th World Glaucoma Association Consensus Meeting, a diverse and representative group of glaucoma clinicians and scientists deliberated on the value and methods of glaucoma screening. Whereas it has been recognized that early detection of glaucoma for treatment is beneficial to preserve the quality of vision and quality of life as glaucoma treatments are often effective, easy to use and well tolerated, the optimal screening strategy for glaucoma has not yet been determined.
ROTA (Retinal Nerve Fiber Layer Optical Texture Analysis) is a patented algorithm designed to detect axonal fiber bundle loss in glaucoma. Unlike conventional Optical Coherence Tomography (OCT) analysis, ROTA uses non-linear transformation to reveal the optical textures and trajectories of axonal fiber bundles, allowing for intuitive and reliable recognition of RNFL abnormalities without the need for normative databases. It can be applied across different OCT models and is particularly effective at detecting focal RNFL defects in early glaucoma and varying degrees of RNFL damage in end-stage glaucoma. The proposed study will address whether the application AI on ROTA is feasible and cost-effective in the setting of glaucoma screening, and whether ROTA would outperform optic disc photography and OCT RNFL thickness assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 50 years or above
排除标准
- •Physically incapacitated
- •Not able to cooperate for clinical examination or optical coherence tomography (OCT) investigation will be excluded
研究组 & 干预措施
Retinal nerve fiber layer optical texture analysis (ROTA)
The RNFL is imaged with OCT for ROTA.
干预措施: ROTA assessment by AI (Diagnostic Test)
Optic disc photography
The optic disc is imaged with color fundus camera.
干预措施: Optic disc assessment by AI (Diagnostic Test)
结局指标
主要结局
Diagnostic performance for detection of glaucoma
时间窗: up to ~1 year
The area under the receiver operating characteristic curve (AUC) for detection of glaucoma
次要结局
- Incremental cost-effectiveness ratios (ICERs) for population screening of glaucoma(up to ~1 year)
- The prevalence of glaucoma(up to ~1 year)
研究者
Professor Christopher K.S. Leung
Clinical Professor
The University of Hong Kong
