the SDMEAI Study: a Multi-center Epidemiological Study

Artificial Intelligence Clinical Trial

Official title:

Effects of Systemic Diseases and Medications on Eye and Artificial Intelligence Model Development: a Multi-center Epidemiological Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04849819
• Other study ID #: IIT2020023
• Status: Not yet recruiting
• Start date: April 22, 2021
• Est. completion date: April 22, 2026

Study information

• Verified date: April 2021
• Source: Sun Yat-sen University
• Contact: Haotian Lin, Ph.D.
• Phone: 13802793086
• Email: haot.lin[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A variety of diseases in the Department of Rheumatology, Immunology, Nephrology, and Gastroenterology can cause eye lesions, and medications can also bring various adverse reactions, which can seriously reduce the quality of patients' daily life, bring additional economic burdens, and even threaten the lives of patients. This study aims to recruit patients from the aboved-mentioned departments and conduct a cross-sectional and cohort study. On one hand, we plan to compare the epidemiological characteristics of ocular lesions of systemic diseases and eye adverse drug effects in patients with rheumatology, immunology, nephrology and gastroenterology, and summarized some epidemiological indices such as prevalence, high-risk factors, etc. On the other hand, we plan to develop an artificial intelligence model after collecting certain case data. By selecting risk factors related to the occurrence of ocular lesions, we aim to train models that can predict the ocular manifestations of systemic diseases and medications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: April 22, 2026
• Est. primary completion date: April 22, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 6-80 years old, gender is not limited

• patients who have been diagnosed with systemic diseases;

• patients who have ever or never used any ocular toxic drugs such as corticosteroids, chloroquine, etc.;

• no history of glaucoma, cataract, scleritis, uveitis, ocular trauma, etc. before enrollment;

• willing to complete follow-ups for at least 2 years.

Exclusion Criteria:

• Mainly use local therapies (intraocular, intra-articular and other non-systemic drug routes);

• history of intraocular surgery (such as lens implantation, vitrectomy, retinal photocoagulation);

• history of glaucoma, cataract, center serous retinopathy, etc.;

• history of various diseases (such as scleritis, uveitis, eye trauma, etc.) that may cause opacity of the eye under the posterior capsule;

• any other diseases or conditions that affect the observation, such as diabetes, low calcium convulsions, long-term exposure to radiation before enrollment;

• subjects with endogenous corticosteroids, or psychiatric diseases.

Related Conditions & MeSH terms

• Adverse Drug Effect on Eye
• Artificial Intelligence
• Drug-Related Side Effects and Adverse Reactions
• Eye Involvement of Systemic Diseaes

Intervention

Drug:
• Corticosteroids, immunosuppressors, biological agents
We do not prescribe new medications to patients but only observe their adverse effects on the eye.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity	Morbiditys of various ocular lesions.	2021.4.22-2025.4.22