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临床试验/NCT07424755
NCT07424755招募中不适用

AI-Empowered Fundus Imaging: Building an Intelligent Platform for Diagnosis, Treatment, and Early Warning of Fundus Diseases

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Data collection outcome

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Cataract patients with posterior staphyloma due to high myopia

干预措施: Multimodal Ocular Imaging and Biometry with Aritifical Intelligence Analysis (Diagnostic Test)

结局指标

主要结局

Data collection outcome

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

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

次要结局

  • AI modeling Analysis(From April 2026 to October 2026)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun Yilin

Resident Physician

Shanghai 10th People's Hospital

研究点 (1)

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