StrabismusNCT05615519
Validation of a Smartphone-based Intelligent Diagnosis and Measurement for Strabismus
An observational study of Strabismus and Exotropia, run by Sun Yat-sen University at 1 site in China.
Trial summary
The current measurement methods of strabismus include the corneal light reflection method, prism alternate covering, etc., which especially rely on the subjective experience of doctors, and there is a large error between different measurers， leading to serious underestimation of strabismus prevalence and insufficient… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Strabismus, Exotropia, Esotropia
- What is being tested?
- A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2022to 1 Apr 2023
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Outpatients from strabismus \& optometry departments or participants from the internet.
Who may be able to join
- The quality of facial videos should be clinically acceptable.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, 510060
Haotian Lin, Ph.D, +86-020-87330274, gddlht@aliyun.com
Haotian Lin, Ph.D
About this study
The current measurement methods of strabismus include the corneal light reflection method, prism alternate covering, etc., which especially rely on the subjective experience of doctors, and there is a large error between different measurers， leading to serious underestimation of strabismus prevalence and insufficient care for strabismus patients. Here, the investigators established and validated an artificial intelligence system to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests. Three-dimensional reconstruction methods are used to digitize the parameters of head and eye positions. This system has been integrated into a smartphone platform to be further validated through hospital-based and population-based clinical trials.
- Conditions
- Strabismus, Exotropia, Esotropia, Vertical Strabismus
- Being tested
- A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.
- Keywords
- Mobile health, Artificaial intelligence medicine, Pediatric ophthalmology
- Medical subject headings
- Strabismus, Exotropia, Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.Diagnostic test
Digital ruler of strabismus
| Study group | Role | What they receive |
|---|---|---|
| Eligible participants for smartphone-based strabismus measurement and diagnosis | Facial videos dataset Facial videos were collected using smartphone and following the programmatic cover tests. Receives: Diagnostic Test: A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of smartphone-based diagnosis
The accurate and the area under curve of the smartphone-based diagnosis.
Measured: Baseline
The consistency between manual and smartphone measurement
Agreement between the manual and automated tests was represented in Bland-Altman plots and concordance correlation coefficients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start2 Dec 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies 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
- 300 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
- NCT05615519
- Sponsor's protocol ID
- DRStrabismus2022
- Status last verified
- Dec 2022
- First submitted
- 7 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang R, Lyu J, Yang Y, Bi S, Yu H, Deng H, Han M, Ma W, Wan M, Peng S, Yu X, Xu F, Lin H. A Smartphone-Based Digital Ruler to Automatically Measure Strabismus in Ophthalmologist-Level: A Prospective, Multicenter Cohort Study. NEJM AI. 2025 Nov;2(11):AIoa2401205. doi: 10.1056/AIoa2401205. Epub 2025 Oct 23.
PubMed 42932718
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Smartphone-based Intelligent Diagnosis and Measurement for Strabismus
- ClinicalTrials.gov ID
- NCT05615519
- Acronym / sponsor ID
- DRStrabismus2022
- Conditions
- Strabismus, Exotropia, Esotropia, Vertical Strabismus
- Keywords
- Mobile health, Artificaial intelligence medicine, Pediatric ophthalmology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 14 Nov 2022 (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 current measurement methods of strabismus include the corneal light reflection method, prism alternate covering, etc., which especially rely on the subjective experience of doctors, and there is a large error between different measurers， leading to serious underestimation of strabismus prevalence and insufficient care for strabismus patients. Here, the investigators established and validated an artificial intelligence system to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests. Three-dimensional reconstruction methods are used to digitize the parameters of head and eye positions. This system has been integrated into a smartphone platform to be further validated through hospital-based and population-based clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible participants for smartphone-based strabismus measurement and diagnosis | – | Diagnostic Test: A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.Facial videos dataset Facial videos were collected using smartphone and following the programmatic cover tests. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients from strabismus \& optometry departments or participants from the internet.
Key inclusion criteria (1 listed)
- The quality of facial videos should be clinically acceptable.
Key exclusion criteria (0 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 |
|---|---|---|
| A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.Digital ruler of strabismus | Diagnostic test | Eligible participants for smartphone-based strabismus measurement and diagnosis |
Primary outcome
The effectiveness of smartphone-based diagnosis
Time frame: Baseline
The accurate and the area under curve of the smartphone-based diagnosis.
The consistency between manual and smartphone measurement
Time frame: Baseline
Agreement between the manual and automated tests was represented in Bland-Altman plots and concordance correlation coefficients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Derived from this study: PubMed 42932718Wang R, Lyu J, Yang Y, Bi S, Yu H, Deng H, Han M, Ma W, Wan M, Peng S, Yu X, Xu F, Lin H. A Smartphone-Based Digital Ruler to Automatically Measure Strabismus in Ophthalmologist-Level: A Prospective, Multicenter Cohort Study. NEJM AI. 2025 Nov;2(11):AIoa2401205. doi: 10.1056/AIoa2401205. Epub 2025 Oct 23.
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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 Strabismus and Exotropia, 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 0 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 5 Dec 2022. 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 Haotian Lin, M.D., Ph.D (8613802793086, haot.lin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of smartphone-based diagnosis (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?
On the ClinicalTrials.gov record for NCT05615519, which also lists 1 linked publication.
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 5 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.