Clinical trial NCT06012058: Glaucoma Screening With Artificial Intelligence
Official title: Glaucoma Screening With Artificial Intelligence - A Randomized Clinical Trial Comparing Retinal Nerve Fiber Layer Optical Texture Analysis and Optic Disc Photography Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: Ophthalmology
Glaucoma
Artificial Intelligence
Retinal Nerve Fiber Layer Optical Texture Analysis
Optic Disc Photography Assessment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Orbis
First posted: 2023-08-25
Enrollment: 3175
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical trial with the primary objective to compare the diagnostic performance of two screening strategies - Retinal nerve fiber layer Optical Texture Analysis (ROTA) assessment by Artificial Intelligence (AI) versus (vs.) optic disc photography assessment by AI or trained graders - for detection of glaucoma in a population-based sample.
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 50 years or above

Exclusion Criteria:

* Physically incapacitated
* Not able to cooperate for clinical examination or optical coherence tomography (OCT) investigation will be excluded

Primary outcomes:
measure: Diagnostic performance for detection of glaucoma
timeFrame: up to ~1 year
Secondary outcomes:
measure: Incremental cost-effectiveness ratios (ICERs) for population screening of glaucoma
timeFrame: up to ~1 year
measure: The prevalence of glaucoma
timeFrame: up to ~1 year
Other outcomes:
measure: Diagnostic performance for detection of macular diseases
timeFrame: up to ~1 year
measure: Incremental cost-effectiveness ratios (ICERs) for population screening of glaucoma and macular diseases
timeFrame: up to ~1 year
measure: The prevalence of macular diseases
timeFrame: up to ~1 year
Locations:
city: Aberdeen
country: Hong Kong
facility: Southern District Wah Kwai Community Centre
city: Kwun Tong
country: Hong Kong
facility: Kwun Tong District Health Centre
Study officials:
affiliation: The University of Hong Kong
name: Christopher Leung
role: PRINCIPAL_INVESTIGATOR
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