OphthalmopathyAINCT03611387
Artificial Intelligence Screening on Patients With Primary Angle Closure Glaucoma
An observational study of Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The Tomey CASIA (Tomey Corporation, Nagoya, Japan) is a novel rapid imaging device that captures high-quality imaging of the entire anterior chamber of the eye over detailed imaging of a single section. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmopathy
- What is being tested?
- CASIA 2 OCT
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 31 Dec 2019
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients ≥18 years old with or without glaucoma
Who may be able to join
- Patient with or without glaucoma
Who cannot join
- Patients with any history of eye surgery (except cataract surgery) including laser procedure.
- Age < =18 years
Trial locations and contacts
1 site in 1 country.
Haotian Lin, M.D,Ph.D contact
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D., 8613802793086, haot.lin@hotmail.com
Jing Li, M.D., +86-20-87330341, Reviewborad_SYsU@163.com
About this study
The Tomey CASIA (Tomey Corporation, Nagoya, Japan) is a novel rapid imaging device that captures high-quality imaging of the entire anterior chamber of the eye over detailed imaging of a single section. In this prospective study, we want to investigate and compare the anatomical structure of the drainage angle of the eye in patients with different types glaucoma using Tomey machine. This study gives us a better understanding of the predictability, validity and accuracy of Tomey machine in the diagnosis of different types of glaucoma. Moreover, the data collected here will be used to create an artificial intelligence (AI) platform to screen certain type of glaucoma.
Read the detailed description
Patients ≥18 years old from ophthalmic clinics with or without glaucoma were enrolled to this respective observational clinical study. However, patients with any history of eye surgery (except cataract surgery) including laser procedure were excluded. The investigators will review patients' medical chart and update any medical history in your medical record. If new scans are needed, investigators will do them at the time of patients' current visit and it will require about 30 mins. CASIA SS-OCT (CASIA 2) is a non-contact scan of the front of the eye with higher resolution and provides deeper, wider and three- dimensional views. It is the newest scan machine. It is not FDA-approved but is approved in many other countries including Japan for patient use. We may perform the scan in the light and dark condition. We may also perform the routine scan to capture images of the anterior part of the eye for comparison purpose. The results of the scanned data will be among patients' medical records. Age, sex and ethnicity within your medical records will also be used for the analysis.
- Conditions
- Ophthalmopathy
- Being tested
- CASIA 2 OCT
- Keywords
- Primary Angle-Closure Glaucoma, Artificial Intelligence
- Medical subject headings
- Eye Diseases, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASIA 2 OCTDevice
Using CASIA 2 OCT to assess the anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods
| Study group | Role | What they receive |
|---|---|---|
| Normal | Patients without any type of glaucoma Receives: Device: CASIA 2 OCT | |
| Primary angle closure glaucoma | Patients with primary angle closure glaucoma Receives: Device: CASIA 2 OCT | |
| Primary open-angle glaucoma | Patients with primary open-angle glaucoma Receives: Device: CASIA 2 OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the CASIA 2 OCT
To compare the clinical applicability, accuracy, and validity of the CASIA 2 OCT (Tomey, Nagoya, Japan) in the assessment of anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods.
Measured: baseline
The sensitivity and specificity of the AI
To create an AI program to reliably screen patients with certain type of glaucoma (such as primary angle closure glaucoma, PACG) using images from CASIA 2 OCT. To test the sensitivity and specificity of the AI program to screen patients with glaucoma using images from CASIA 2 OCT. Another database comprised of CASIA 2 OCT images will be created and used to test the AI program. The diagnosis based on the AI program will be compared with diagnosis from glaucoma specialist.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmopathyStudies 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
- 1,500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611387
- Sponsor's protocol ID
- CCPMOH2018-China-4
- Acronym
- AI
- Status last verified
- Jul 2018
- First submitted
- 26 Jul 2018
- Last updated
- 2 Aug 2018
- 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 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Screening on Patients With Primary Angle Closure Glaucoma
- ClinicalTrials.gov ID
- NCT03611387
- Acronym / sponsor ID
- AI / CCPMOH2018-China-4
- Conditions
- Ophthalmopathy
- Keywords
- Primary Angle-Closure Glaucoma, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- University of California
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Aug 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.
The Tomey CASIA (Tomey Corporation, Nagoya, Japan) is a novel rapid imaging device that captures high-quality imaging of the entire anterior chamber of the eye over detailed imaging of a single section. In this prospective study, we want to investigate and compare the anatomical structure of the drainage angle of the eye in patients with different types glaucoma using Tomey machine. This study gives us a better understanding of the predictability, validity and accuracy of Tomey machine in the diagnosis of different types of glaucoma. Moreover, the data collected here will be used to create an artificial intelligence (AI) platform to screen certain type of glaucoma.
Detailed description
Patients ≥18 years old from ophthalmic clinics with or without glaucoma were enrolled to this respective observational clinical study. However, patients with any history of eye surgery (except cataract surgery) including laser procedure were excluded. The investigators will review patients' medical chart and update any medical history in your medical record. If new scans are needed, investigators will do them at the time of patients' current visit and it will require about 30 mins. CASIA SS-OCT (CASIA 2) is a non-contact scan of the front of the eye with higher resolution and provides deeper, wider and three- dimensional views. It is the newest scan machine. It is not FDA-approved but is approved in many other countries including Japan for patient use. We may perform the scan in the light and dark condition. We may also perform the routine scan to capture images of the anterior part of the eye for comparison purpose. The results of the scanned data will be among patients' medical records. Age, sex and ethnicity within your medical records will also be used for the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: CASIA 2 OCTPatients without any type of glaucoma |
| Primary angle closure glaucoma | – | Device: CASIA 2 OCTPatients with primary angle closure glaucoma |
| Primary open-angle glaucoma | – | Device: CASIA 2 OCTPatients with primary open-angle glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients ≥18 years old with or without glaucoma
Key inclusion criteria (1 listed)
- Patient with or without glaucoma
Key exclusion criteria (2 listed)
- Patients with any history of eye surgery (except cataract surgery) including laser procedure.
- Age < =18 years
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 |
|---|---|---|
| CASIA 2 OCTUsing CASIA 2 OCT to assess the anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods | Device | Normal, Primary angle closure glaucoma, Primary open-angle glaucoma |
Primary outcome
The accuracy of the CASIA 2 OCT
Time frame: baseline
To compare the clinical applicability, accuracy, and validity of the CASIA 2 OCT (Tomey, Nagoya, Japan) in the assessment of anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods.
The sensitivity and specificity of the AI
Time frame: baseline
To create an AI program to reliably screen patients with certain type of glaucoma (such as primary angle closure glaucoma, PACG) using images from CASIA 2 OCT. To test the sensitivity and specificity of the AI program to screen patients with glaucoma using images from CASIA 2 OCT. Another database comprised of CASIA 2 OCT images will be created and used to test the AI program. The diagnosis based on the AI program will be compared with diagnosis from glaucoma specialist.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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.
Haotian Lin, M.D,Ph.D contact
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 Ophthalmopathy, run by Sun Yat-sen University 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 2 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 2 Aug 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 Jing Li, M.D (+86-20-87330341, Reviewborad_SYsU@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of the CASIA 2 OCT (time frame: baseline). 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 2 Aug 2018.