High MyopiaNCT07424755
AI-Empowered Fundus Platform
An observational study of High Myopia, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High Myopia
- What is being tested?
- Multimodal Ocular Imaging and Biometry with Aritifical Intelligence Analysis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai
Yiwen Hu, +86 18019320181, 1006108590@qq.com
About this study
Official title: AI-Empowered Fundus Imaging: Building an Intelligent Platform for Diagnosis, Treatment, and Early Warning of Fundus Diseases
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
- Being tested
- Multimodal Ocular Imaging and Biometry with Aritifical Intelligence Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Ocular Imaging and Biometry with Aritifical Intelligence AnalysisDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Cataract patients with posterior staphyloma due to high myopia | Not described Receives: Diagnostic Test: Multimodal Ocular Imaging and Biometry with Aritifical Intelligence Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection outcome
Demographic data clasification of posterior scleral staphyloma visual acuity and imaging data
Measured: From October 2024 to April 2026 (Data collection from patients who visited the hospital before October 2024)
Secondary outcomes (1)
AI modeling Analysis
Diagnostic performance of the AI model for posterior scleral staphyloma. Area under the receiver operating characteristic curve (AUC-ROC) of the AI model.
Accuracy, sensitivity, and specificity of the model in detecting posterior scleral staphyloma.
Comparison of AI performance and doctors' performance
Measured: From April 2026 to October 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Oct 2024
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yilin, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424755
- Sponsor's protocol ID
- SHSY-LYZX-413
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Empowered Fundus Imaging: Building an Intelligent Platform for Diagnosis, Treatment, and Early Warning of Fundus Diseases
- ClinicalTrials.gov ID
- NCT07424755
- Acronym / sponsor ID
- SHSY-LYZX-413
- Conditions
- High Myopia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract patients with posterior staphyloma due to high myopia | – | Diagnostic Test: Multimodal Ocular Imaging and Biometry with Aritifical Intelligence Analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Ocular Imaging and Biometry with Aritifical Intelligence AnalysisThe 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 | Diagnostic test | Cataract patients with posterior staphyloma due to high myopia |
Primary outcome
Data collection outcome
Time frame: 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
1 secondary outcome
AI modeling Analysis
Time frame: From April 2026 to October 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Myopia, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yiwen Hu (+86 18019320181, 1006108590@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection outcome (time frame: From October 2024 to April 2026 (Data collection from patients who visited the hospital before October 2024)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.