Glaucoma EyeNCT03682783
Artificial Intelligence-assisted Glaucoma Screening (AIAGS)
An observational study of Glaucoma Eye, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study will develop an artificial intelligence (AI) program for the screening of glaucoma. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Eye
- What is being tested?
- Fundus Image
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Oct 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Both glaucoma and non-glaucoma patients who can complete fundus image test will be enrolled.
Who may be able to join
- able to complete fundus images
Who cannot join
- unable to complete fundus images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development of Artificial Intelligence-assisted Glaucoma Screening Program
This study will develop an artificial intelligence (AI) program for the screening of glaucoma.
Read the detailed description
We have realized that the glaucomatous optic neuropathy is irreversible. But if early detection and early intervention can be performed to control the development of the disease, it can greatly reduce the blindness rate of glaucoma, improve the life quality and physiological and mental health of patients, and alleviate the social burden. Therefore, screening and early diagnosis of glaucoma is the focus of glaucoma prevention.
China has a population of 1.3 billion, which greatly increase the difficulty of disease screening. In recent years, the intersection of artificial intelligence (AI) technology and modern medicine has made efficient and rapid disease screening possible.
- Conditions
- Glaucoma Eye
- Being tested
- Fundus Image
- Keywords
- Artificial Intelligence; Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus ImageDiagnostic test
Fundus image of optic nerve
| Study group | Role | What they receive |
|---|---|---|
| Fundus Image | Glaucomatous and Non-glaucomatous fundus images that have been taken from the last 5 years in Shanghai General hospital. Receives: Diagnostic Test: Fundus Image |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specificity of the algorithm for diagnosing glaucoma
The specificity of the algorithm for diagnosing glaucoma will be calculated ...
Measured: from January 2020 to March 2021
The sensitivity of the algorithm for diagnosing glaucoma
The sensitivity of the algorithm for diagnosing glaucoma will be calculated .
Measured: from January 2020 to March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma EyeStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiyan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Haiyan Wang, Ph.D., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682783
- Sponsor's protocol ID
- 81300776
- Status last verified
- Sep 2018
- First submitted
- 21 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Artificial Intelligence-assisted Glaucoma Screening Program
- ClinicalTrials.gov ID
- NCT03682783
- Acronym / sponsor ID
- 81300776
- Conditions
- Glaucoma Eye
- Keywords
- Artificial Intelligence; Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 25 Sep 2018 (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.
This study will develop an artificial intelligence (AI) program for the screening of glaucoma.
Detailed description
We have realized that the glaucomatous optic neuropathy is irreversible. But if early detection and early intervention can be performed to control the development of the disease, it can greatly reduce the blindness rate of glaucoma, improve the life quality and physiological and mental health of patients, and alleviate the social burden. Therefore, screening and early diagnosis of glaucoma is the focus of glaucoma prevention.
China has a population of 1.3 billion, which greatly increase the difficulty of disease screening. In recent years, the intersection of artificial intelligence (AI) technology and modern medicine has made efficient and rapid disease screening possible.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fundus Image | – | Diagnostic Test: Fundus ImageGlaucomatous and Non-glaucomatous fundus images that have been taken from the last 5 years in Shanghai General hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both glaucoma and non-glaucoma patients who can complete fundus image test will be enrolled.
Key inclusion criteria (1 listed)
- able to complete fundus images
Key exclusion criteria (1 listed)
- unable to complete fundus images
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 |
|---|---|---|
| Fundus ImageFundus image of optic nerve | Diagnostic test | Fundus Image |
Primary outcome
The specificity of the algorithm for diagnosing glaucoma
Time frame: from January 2020 to March 2021
The specificity of the algorithm for diagnosing glaucoma will be calculated ...
The sensitivity of the algorithm for diagnosing glaucoma
Time frame: from January 2020 to March 2021
The sensitivity of the algorithm for diagnosing glaucoma will be calculated .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
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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.
Haiyan Wang, Ph.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma Eye, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Haiyan Wang, Ph.D. (+86 15000096256, catherinecnc81@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The specificity of the algorithm for diagnosing glaucoma (time frame: from January 2020 to March 2021). The study lists 2 primary outcomes in all. 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 25 Sep 2018.