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the SDMEAI Study: a Multi-center Epidemiological Study

Sun Yat-sen University logo

Sun Yat-sen University

Status

Not yet enrolling

Conditions

Adverse Drug Effect on Eye
Artificial Intelligence
Eye Involvement of Systemic Diseaes

Treatments

Drug: Corticosteroids, immunosuppressors, biological agents

Study type

Observational

Funder types

Other

Identifiers

NCT04849819
IIT2020023

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

6 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 3 patient groups

never receive systemic medications
ever user of systemic medications
Treatment:
Drug: Corticosteroids, immunosuppressors, biological agents
current user of systemic medications
Treatment:
Drug: Corticosteroids, immunosuppressors, biological agents

Trial contacts and locations

0

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Central trial contact

Haotian Lin, Ph.D.

Data sourced from clinicaltrials.gov

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