MyopiaNCT04014725
Validation of the Utility of Myopia Intelligent Diagnostic System
A study testing Myopia Intelligent Diagnostic System in people with Myopia, run by Sun Yat-sen University.
Trial summary
The screening of myopia via artificial intelligence represents an challenge in computational medicine. Here, the investigators use "deep learning" to create an automatic diagnostic system for myopia screening using ocular appearance images. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Myopia
- What is being tested?
- Myopia Intelligent Diagnostic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2019to 1 Aug 2019
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Student aged 6-18
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of the Utility of Myopia Intelligent Diagnostic System: A Clinical Trial
The screening of myopia via artificial intelligence represents an challenge in computational medicine. Here, the investigators use "deep learning" to create an automatic diagnostic system for myopia screening using ocular appearance images. The investigator also use this system and conduct clinical trial to validate its performance.
- Conditions
- Myopia
- Being tested
- Myopia Intelligent Diagnostic System
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myopia Intelligent Diagnostic SystemDevice
An artificial intelligence to make diagnosis of myopia using ocular appearance images
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients for AI test | Experimental | Not described Receives: Device: Myopia Intelligent Diagnostic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The AUC of the Myopia Intelligent Diagnostic System
Measured: up to 3 month
Secondary outcomes (2)
The sensitivity of the Myopia Intelligent Diagnostic System
Measured: up to 3 month
The specificity of the Myopia Intelligent Diagnostic System
Measured: up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start10 Jul 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014725
- Sponsor's protocol ID
- CCPMOH2019-China-2
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Utility of Myopia Intelligent Diagnostic System: A Clinical Trial
- ClinicalTrials.gov ID
- NCT04014725
- Acronym / sponsor ID
- CCPMOH2019-China-2
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Jul 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 10 Jul 2019 (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.
The screening of myopia via artificial intelligence represents an challenge in computational medicine. Here, the investigators use "deep learning" to create an automatic diagnostic system for myopia screening using ocular appearance images. The investigator also use this system and conduct clinical trial to validate its performance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients for AI test | Experimental | Device: Myopia Intelligent Diagnostic System |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Student aged 6-18
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Myopia Intelligent Diagnostic SystemAn artificial intelligence to make diagnosis of myopia using ocular appearance images | Device | Eligible patients for AI test |
Primary outcome
The AUC of the Myopia Intelligent Diagnostic System
Time frame: up to 3 month
2 secondary outcomes
The sensitivity of the Myopia Intelligent Diagnostic System
Time frame: up to 3 month
The specificity of the Myopia Intelligent Diagnostic System
Time frame: up to 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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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?
A study testing Myopia Intelligent Diagnostic System in people with Myopia, 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 10 Jul 2019. 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 Yahan Yang (+8615521013933, yah.yang39@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The AUC of the Myopia Intelligent Diagnostic System (time frame: up to 3 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 10 Jul 2019.