AI-Empowered Fundus Platform

NCT07424755 | Recruiting

• 1 other identifier: SHSY-LYZX-413
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

According to estimates by the World Health Organization, approximately half of the global adult population currently suffers from varying degrees of myopia. In urban areas of China, the myopia rate among primary school students has reached about 40%, and can exceed 80% in high school students. The proportion of patients with high myopia (refractive error greater than 600 degrees) is also increasing year by year. This group is more prone to severe visual problems, including an increased risk of complications such as cataracts, glaucoma, and macular degeneration. Pathological myopia is the main risk factor for vision loss caused by high myopia. In such patients, the elongation of the ocular axis leads to local thinning and protrusion of the posterior pole of the eyeball, forming a posterior scleral staphyloma. Posterior scleral staphyloma is the most representative pathological feature of pathological myopia. Local dilation of the choroid leads to thinning and stretching of the retina, which may ultimately cause problems such as macular retinal schisis, seriously affecting vision and even leading to blindness. This project aims to develop a multimodal intelligent screening system by combining the excellent imaging technology and advanced artificial intelligence (AI) of the Optos non-mydriatic ultra-wide-angle laser scanning ophthalmoscope, B-scan ultrasonography ophthalmic diagnostic instrument, and optical coherence tomography (OCT). The system is designed to achieve precise identification and assessment of ocular fundus diseases, especially pathological myopia, and particularly the core condition of posterior scleral staphyloma (PSS). Simultaneously, a vision prediction model will be constructed to assist doctors in formulating personalized diagnosis and treatment strategies, predicting the trend of vision deterioration, and enhancing the effectiveness of early intervention. This system is expected to significantly improve the prevention and control of pathological myopia, reduce the risk of blindness, and play a pivotal role in telemedicine services, benefiting people in remote areas and promoting public health equity and service quality.

Conditions

High Myopia

Outcome Measures

Primary Outcomes (1)

• Data collection outcome

  Demographic data clasification of posterior scleral staphyloma visual acuity and imaging data

  From October 2024 to April 2026 (Data collection from patients who visited the hospital before October 2024)

Secondary Outcomes (1)

• AI modeling Analysis

  From April 2026 to October 2026

Study Arms (1)

Cataract patients with posterior staphyloma due to high myopia

Diagnostic Test: Multimodal Ocular Imaging and Biometry with Aritifical Intelligence Analysis

Interventions

Multimodal Ocular Imaging and Biometry with Aritifical Intelligence Analysis DIAGNOSTIC_TEST

The patient underwent a complete set of fundus color photography, B-scan ultrasonography, and OCT imaging during the consultation, and preoperative baseline data, including demographic information, health status, ophthalmic history, and ocular biometric parameters, were collected and recorded in detail

Cataract patients with posterior staphyloma due to high myopia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study enrolled patients diagnosed with high myopia and posterior staphyloma (PSS) who visited the Department of Ophthalmology, Shanghai Tenth People's Hospital before October 2024. Sample Size：A total of 1,000 patients (600 for training, 200 for validation, and 200 for internal testing) from the hospital cohort, contributing approximately 6,000 multimodal images.

You may qualify if:

• Patients with a diagnosis of cataract and high myopia and posterior staphyloma, who underwent comprehensive ophthalmic examinations including ultra-widefield fundus photography (Optos), B-scan ultrasonography, and optical coherence tomography (OCT). Baseline data, including demographics, health status, ophthalmic history, and ocular biometric parameters, were completely documented.

You may not qualify if:

• Patients with poor-quality images affecting PSS identification, severe coexisting ocular diseases including glaucoma, diabetic retinopathy that cause media opacities, or severe systemic diseases that could interfere with the study outcomes.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, China

RECRUITING

Central Study Contacts

yiwen Hu

CONTACT

+86 18019320181; 1006108590@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: October 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

CN (1)