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Development and Validation of Explainbale Glaucoma Diagnostic AI System Based on Large Language Models

Development and Validation of Explainbale Glaucoma Diagnostic AI System Based on Large Language Models

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101012
Enrollment
Unknown
Registered
2025-04-18
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glaucoma

Interventions

Gold Standard:(1) glaucomatous optic neuropathy (2) retinal nerve fiber layer (RNFL) defect corresponds to visual field defect.
Index test:a precise diagnosis and clinical decision system for glaucoma based on multi-modal large language model

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Glaucoma: 1. age >=18 years; 2. Complete fundus photographs, VF, OCT reports 3. glaucoma optic neuropathy, which must meet the following diagnostic criteria: (1) glaucomatous optic neuropathy (cup-to-disc ratio =0.7, and/or binocular C/D difference greater than 0.2, and/or supratemporal and infratemporal discs perpendicular to the width of less than or equal to 0.1 optic discs, and/or RNFL defects, and/or bleeding of optic discs, and/or local incisal disc formation); (2) retinal nerve fiber layer (RNFL) defect corresponds to visual field defect. 4. The patient has at least two consecutive reliable visual field test results. 5. Patients voluntarily participated in the study and signed informed consent; Non-glaucoma: 1. age >=18 years; 2. Complete fundus photos, VF, OCT report 3. patients without glaucomatous optic neuropathy; 4. The patient voluntarily participates in this study and signs an informed consent form;

Exclusion criteria

Exclusion criteria: 1.Glaucoma and non-glaucoma: a. Unreliable visual field test results with one of the following: (1) fixation loss rate >=20% (2) false-positive rate >=15% (3) false-negative rate >=33% 2. History of intraocular surgery or ocular trauma; 3. Severe opacity of cornea or interstitial refraction; 4. There are various types of fundus diseases affecting the collection of eye parameters or interfering with visual field detection; 5. Complicated with severe systemic disease.

Design outcomes

Primary

MeasureTime frame
Area Under the ROC Curve;

Secondary

MeasureTime frame
Rationality of the glaucoma differential diagnosis based on the large language model diagnostic system and physicians' trust in the system.;Specificity;Sensitivity;

Countries

China

Contacts

Public ContactFei Li

The Zhongshan Ophthalmic Center,Sun Yat-sen University

lifei.aletheus@gmail.com+86 20 66610720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026