the SDMEAI Study: a Multi-center Epidemiological Study

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Artificial Intelligence; Eye Involvement of Systemic Diseaes; Adverse Drug Effect on Eye
• Intervention / Treatment: Drug: Corticosteroids, immunosuppressors, biological agents

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Haotian Lin, Ph.D.; Phone Number: 13802793086; Email: haot.lin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We will recruit patients from the Sixth Affiliated Hospital, Sun Yat-Sen University and invite them to take ocular examinations in Zhongshan Ophthalmic Center, Sun Yat-Sen University. The Sixth Affiliated Hospital, Sun Yat-Sen University is a tertiary general hospital in Guangzhou, Guangdong, China. It has various departments, such as rheumatology and immunology department, nephrology departent and gastroenterology department, providing abundant cases of systemic diseases.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
never receive systemic medications
ever user of systemic medications	Drug: Corticosteroids, immunosuppressors, biological agents; We do not prescribe new medications to patients but only observe their adverse effects on the eye.
current user of systemic medications	Drug: Corticosteroids, immunosuppressors, biological agents; We do not prescribe new medications to patients but only observe their adverse effects on the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbidity	Morbiditys of various ocular lesions.	2021.4.22-2025.4.22

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 22, 2021
• Primary Completion (ANTICIPATED): April 22, 2025
• Study Completion (ANTICIPATED): April 22, 2026

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (ACTUAL): April 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: IIT2020023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No