Eye Involvement of Systemic DiseaesNCT04849819
the SDMEAI Study: a Multi-center Epidemiological Study
An observational study of Eye Involvement of Systemic Diseaes and Adverse Drug Effect on Eye, run by Sun Yat-sen University.
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… Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Involvement of Systemic Diseaes, Adverse Drug Effect on Eye, Artificial Intelligence
- What is being tested?
- Corticosteroids, immunosuppressors, biological agents
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2021to 22 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- Corticosteroids, immunosuppressors, biological agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroids, immunosuppressors, biological agentsDrug
We do not prescribe new medications to patients but only observe their adverse effects on the eye.
| Study group | Role | What they receive |
|---|---|---|
| never receive systemic medications | Not described | |
| ever user of systemic medications | Not described Receives: Drug: Corticosteroids, immunosuppressors, biological agents | |
| current user of systemic medications | Not described Receives: Drug: Corticosteroids, immunosuppressors, biological agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
Morbiditys of various ocular lesions.
Measured: 2021.4.22-2025.4.22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start22 Apr 2021 (estimated)
- Primary completion22 Apr 2025 (estimated)
- Study completion22 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Involvement of Systemic DiseaesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849819
- Sponsor's protocol ID
- IIT2020023
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systemic Diseases and Medications on Eye and Artificial Intelligence Model Development: a Multi-center Epidemiological Study
- ClinicalTrials.gov ID
- NCT04849819
- Acronym / sponsor ID
- IIT2020023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 22 Apr 2021 (estimated)
- Primary completion
- 22 Apr 2025 (estimated)
- Study completion
- 22 Apr 2026 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| never receive systemic medications | – | – |
| ever user of systemic medications | – | Drug: Corticosteroids, immunosuppressors, biological agents |
| current user of systemic medications | – | Drug: Corticosteroids, immunosuppressors, biological agents |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroids, immunosuppressors, biological agentsWe do not prescribe new medications to patients but only observe their adverse effects on the eye. | Drug | current user of systemic medications, ever user of systemic medications |
Primary outcome
morbidity
Time frame: 2021.4.22-2025.4.22
Morbiditys of various ocular lesions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haotian Lin, Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Involvement of Systemic Diseaes and Adverse Drug Effect on Eye, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haotian Lin, Ph.D. (13802793086, haot.lin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity (time frame: 2021.4.22-2025.4.22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.