Clinical trial NCT04849819: the SDMEAI Study: a Multi-center Epidemiological Study
Official title: Effects of Systemic Diseases and Medications on Eye and Artificial Intelligence Model Development: a Multi-center Epidemiological Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Eye Involvement of Systemic Diseaes
Adverse Drug Effect on Eye
Artificial Intelligence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: morbidity
timeFrame: 2021.4.22-2025.4.22
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: