UveitisNCT04705103
Development of AI Model for Uveitis Progression and Prognosis
An observational study of Uveitis, run by Sun Yat-sen University.
Trial summary
Uveitis is a recurrent inflammation of the eye that can lead to vision loss with various and complicated etiologies. There are many difficulties in uveitis management due to the requirement of long-term monitoring and treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uveitis
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2021to 30 Dec 2022
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Initial stage of uveitis: The first episode of uveitis without treatment; 2. Remission of uveitis: Uveitis caused by various reasons in the stable disease period of more than 3 months without treatment; 3. Relapse of uveitis: After discontinuation of uveitis treatment, the disease stabilized for more than 3 months.
Who may be able to join
- Participants who were diagnosed as uveitis, including the initial stage or relapse, or remission of uveitis.
Who cannot join
- Participants who cannnot cooperate with ocualr examination.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development of Artificial Intelligence Prediction Model for Uveitis Progression and Prognosis
Uveitis is a recurrent inflammation of the eye that can lead to vision loss with various and complicated etiologies. There are many difficulties in uveitis management due to the requirement of long-term monitoring and treatment. This study intends to establish a longitudinal cohort of uveitis patients to colloect multimodal clinical data including visual acuity, intraocular pressure, anterior segment photography, fundus photography, fluoroscopy and other ophthalmic examinations, and final diagnosis in order to use artificial intelligence and deep learning technology to extract ocular features, explore the association with the progression and prognosis of uveitis and finally establish a disease management model for uveitis.
- Conditions
- Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| initial | Not described | |
| relapse | Not described | |
| inactive | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
uveitis progression
uveitis progression is divided into remission, relapse, or initial
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start10 Jan 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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
- 450 participants (estimated)
- Target duration
- 6 Months
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705103
- Sponsor's protocol ID
- 2020KYPJ185
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 12 Jan 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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Artificial Intelligence Prediction Model for Uveitis Progression and Prognosis
- ClinicalTrials.gov ID
- NCT04705103
- Acronym / sponsor ID
- 2020KYPJ185
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 12 Jan 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.
Uveitis is a recurrent inflammation of the eye that can lead to vision loss with various and complicated etiologies. There are many difficulties in uveitis management due to the requirement of long-term monitoring and treatment. This study intends to establish a longitudinal cohort of uveitis patients to colloect multimodal clinical data including visual acuity, intraocular pressure, anterior segment photography, fundus photography, fluoroscopy and other ophthalmic examinations, and final diagnosis in order to use artificial intelligence and deep learning technology to extract ocular features, explore the association with the progression and prognosis of uveitis and finally establish a disease management model for uveitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| initial | – | – |
| relapse | – | – |
| inactive | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Initial stage of uveitis: The first episode of uveitis without treatment; 2. Remission of uveitis: Uveitis caused by various reasons in the stable disease period of more than 3 months without treatment; 3. Relapse of uveitis: After discontinuation of uveitis treatment, the disease stabilized for more than 3 months.
Key inclusion criteria (1 listed)
- Participants who were diagnosed as uveitis, including the initial stage or relapse, or remission of uveitis.
Key exclusion criteria (1 listed)
- Participants who cannnot cooperate with ocualr examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
uveitis progression
Time frame: up to 1 month
uveitis progression is divided into remission, relapse, or initial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, 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 1 inclusion and 1 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 12 Jan 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, M.D.,Ph.D (13802793086, gddlht@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uveitis progression (time frame: up to 1 month). 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 12 Jan 2021.