Ophthalmological DisorderNCT04416776
Validation of the Utility of Strabismus Intelligent Diagnostic System
An observational study of Ophthalmological Disorder and Strabismus, run by Sun Yat-sen University at 1 site in China.
Trial summary
Strabismus affects approximately 0.8%-6.8% of the world's population and appears by the age of 3 years in 65% of affected individuals. Manual measurement of deviation is often laborious and highly dependent on the experience of the specialist and the cooperation of the patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ophthalmological Disorder, Strabismus
- What is being tested?
- Strabismus diagnostic system.
- How many people
- 323 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 10 Jun 2020
- 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: A prospective study to validate the accuracy of the strabismus intelligent diagnostic system in the clinical practice.
Who may be able to join
- Patients in the outpatient clinic of strabismus department.
Who cannot join
- Patients or their parents diagree to participate in the trial.
- Patients with blepharoptosis.
- Patients can't facing forward or lacking fixation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Keli Mao, M.D., 87330493, maokl@mail2.sysu.edu.cn
About this study
Official title: Validation of the Utility of Strabismus Intelligent Diagnostic System: A Clinical Trial
Strabismus affects approximately 0.8%-6.8% of the world's population and appears by the age of 3 years in 65% of affected individuals. Manual measurement of deviation is often laborious and highly dependent on the experience of the specialist and the cooperation of the patients. Current strabismus evaluation technologies are heavily dependent on model eyes. Here, the investigators use deep learning to develop an artificial intelligence (AI) platform consisting of three deep learning (DL) systems to screen strabismus, evaluate deviation and propose a surgical plan based on corneal light-reflection photos. The investigator also conduct clinical trial to validate its versatility in clinical practice.
- Conditions
- Ophthalmological Disorder, Strabismus
- Being tested
- Strabismus diagnostic system.
- Medical subject headings
- Eye Diseases, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strabismus diagnostic system.Drug
An AI platform based on corneal light-reflection photos to facilitate the diagnosis and angle evaluation of strabismus and to provide advice for surgical planning.
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients for AI test | Device: strabismus diagnostic system. Receives: Drug: Strabismus diagnostic system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of accurate, mistaken and miss detection of the diagnostic system.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Sep 2019
- Primary completion10 Jun 2020 (estimated)
- Study completion10 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmological DisorderStudies 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
- 323 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
- NCT04416776
- Sponsor's protocol ID
- SIDS-2020
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 4 Jun 2020
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Utility of Strabismus Intelligent Diagnostic System: A Clinical Trial
- ClinicalTrials.gov ID
- NCT04416776
- Acronym / sponsor ID
- SIDS-2020
- Conditions
- Ophthalmological Disorder, Strabismus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 10 Jun 2020 (estimated)
- Study completion
- 10 Jun 2020 (estimated)
- First posted
- 4 Jun 2020 (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.
Strabismus affects approximately 0.8%-6.8% of the world's population and appears by the age of 3 years in 65% of affected individuals. Manual measurement of deviation is often laborious and highly dependent on the experience of the specialist and the cooperation of the patients. Current strabismus evaluation technologies are heavily dependent on model eyes. Here, the investigators use deep learning to develop an artificial intelligence (AI) platform consisting of three deep learning (DL) systems to screen strabismus, evaluate deviation and propose a surgical plan based on corneal light-reflection photos. The investigator also conduct clinical trial to validate its versatility in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients for AI test | – | Drug: Strabismus diagnostic system.Device: strabismus diagnostic system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A prospective study to validate the accuracy of the strabismus intelligent diagnostic system in the clinical practice.
Key inclusion criteria (1 listed)
- Patients in the outpatient clinic of strabismus department.
Key exclusion criteria (3 listed)
- Patients or their parents diagree to participate in the trial.
- Patients with blepharoptosis.
- Patients can't facing forward or lacking fixation.
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 |
|---|---|---|
| Strabismus diagnostic system.An AI platform based on corneal light-reflection photos to facilitate the diagnosis and angle evaluation of strabismus and to provide advice for surgical planning. | Drug | Eligible patients for AI test |
Primary outcome
The proportion of accurate, mistaken and miss detection of the diagnostic system.
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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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.
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 Ophthalmological Disorder and Strabismus, 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 3 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 4 Jun 2020. 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 Keli Mao, M.D (87330493, maokl@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of accurate, mistaken and miss detection of the diagnostic system. (time frame: up to 3 years). 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 4 Jun 2020.