the SDMEAI Study: a Multi-center Epidemiological Study

Not yet recruiting

• Conditions: Adverse Drug Effect on Eye; Eye Involvement of Systemic Diseaes; Artificial Intelligence
• Interventions: Drug: Corticosteroids, immunosuppressors, biological agents

• Registration Number: NCT04849819
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-15
• Last Update Submitted: 2021-04-16
• Study First Posted: 2021-04-19
• Last Update Posted: 2021-04-20
• Study Start: 2021-04-22
• Primary Completion: 2025-04-22
• Study Completion: 2026-04-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ever user of systemic medications	Corticosteroids, immunosuppressors, biological agents	-
current user of systemic medications	Corticosteroids, immunosuppressors, biological agents	-

Primary Outcome Measures

Name	Time	Method
morbidity	2021.4.22-2025.4.22	Morbiditys of various ocular lesions.