Congenital PtosisNCT07078552
Research on Precision Diagnosis and Treatment Decision of Common Eye Diseases Based on Artificial Intelligence
An observational study of Congenital Ptosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to investigate the clinical features of congenital ptosis in children by analyzing eyelid movement captured through smartphone videos. The main question it aims to answer is: Can video-based eyelid measurements and levator muscle function grading provide useful guidance for the… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Ptosis
- What is being tested?
- ptosis
- How many people
- 368 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 May 2025
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Inclusion criteria required participants aged ≤18 years with compliance during video recording. Congenital ptosis diagnosis mandated documented symptom onset within the first year of life and bilateral or unilateral MRD1 of < 2.5 mm. Healthy controls exhibited age-appropriate ocular development without eyelid abnormalities.
Who may be able to join
- participants aged ≤18 years with compliance during video recording. Congenital ptosis diagnosis mandated documented symptom onset within the first year of life and bilateral or unilateral MRD1 of < 2.5 mm
Who cannot join
- acquired ptosis, myasthenia gravis, Marcus Gunn syndrome, eyelid deformities, or prior ophthalmic surgery
Trial locations and contacts
1 site in 1 country.
China1 site
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
About this study
The goal of this observational study is to investigate the clinical features of congenital ptosis in children by analyzing eyelid movement captured through smartphone videos. The main question it aims to answer is:
Can video-based eyelid measurements and levator muscle function grading provide useful guidance for the treatment of congenital ptosis in children?
Participants are children diagnosed with congenital ptosis. Their blinking behavior will be recorded using a smartphone, and eyelid morphology and muscle strength will be assessed from the video data.
Read the detailed description
In this study, we developed a two-module system for the evaluation of congenital ptosis in children based on smartphone video recordings. The first module performs morphological measurements of eyelid parameters (e.g., palpebral fissure height, margin reflex distance) extracted from blink videos. The accuracy of this module was assessed through agreement analysis between automated measurements and manual measurements performed by clinicians.
The second module focuses on levator function grading. The automated grading results were compared against clinical assessments by senior oculoplastic specialists, which served as the gold standard, to evaluate the model's accuracy. Additionally, we compared the model's performance to that of junior ophthalmology residents to assess the system's clinical assistive value in real-world scenarios.
Based on these modules, we developed a smartphone-based application for remote ptosis assessment. A multi-center clinical validation study was designed to evaluate the feasibility, consistency, and generalizability of the system in different clinical settings.
- Conditions
- Congenital Ptosis
- Being tested
- ptosis
- Keywords
- Congenital Ptosis, levator function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ptosisOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| congenital ptosis | Not described Receives: Other: ptosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
levator function testing
Measured: One-time assessment; results available within 1 week of data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2024
- Primary completion1 May 2025
- Study completion1 May 2025
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 Congenital PtosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Tianjin Eye Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078552
- Sponsor's protocol ID
- 2023-1035
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li H, Cao J, Duan S, Hu S, Lou L, Lin M, Jian T, Shao J, Zhang X, Chen P, He Y, Wang J, Huang S, Ye J. From blink to care: smartphone video-based functional analysis and personalized management in pediatric blepharoptosis. NPJ Digit Med. 2026 Mar 18;9(1):358. doi: 10.1038/s41746-026-02510-y.
PubMed 41844953
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Precision Diagnosis and Treatment Decision of Common Eye Diseases Based on Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07078552
- Acronym / sponsor ID
- 2023-1035
- Conditions
- Congenital Ptosis
- Keywords
- Congenital Ptosis, levator function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Tianjin Eye Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 22 Jul 2025 (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 goal of this observational study is to investigate the clinical features of congenital ptosis in children by analyzing eyelid movement captured through smartphone videos. The main question it aims to answer is:
Can video-based eyelid measurements and levator muscle function grading provide useful guidance for the treatment of congenital ptosis in children?
Participants are children diagnosed with congenital ptosis. Their blinking behavior will be recorded using a smartphone, and eyelid morphology and muscle strength will be assessed from the video data.
Detailed description
In this study, we developed a two-module system for the evaluation of congenital ptosis in children based on smartphone video recordings. The first module performs morphological measurements of eyelid parameters (e.g., palpebral fissure height, margin reflex distance) extracted from blink videos. The accuracy of this module was assessed through agreement analysis between automated measurements and manual measurements performed by clinicians.
The second module focuses on levator function grading. The automated grading results were compared against clinical assessments by senior oculoplastic specialists, which served as the gold standard, to evaluate the model's accuracy. Additionally, we compared the model's performance to that of junior ophthalmology residents to assess the system's clinical assistive value in real-world scenarios.
Based on these modules, we developed a smartphone-based application for remote ptosis assessment. A multi-center clinical validation study was designed to evaluate the feasibility, consistency, and generalizability of the system in different clinical settings.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| congenital ptosis | – | Other: ptosis |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Inclusion criteria required participants aged ≤18 years with compliance during video recording. Congenital ptosis diagnosis mandated documented symptom onset within the first year of life and bilateral or unilateral MRD1 of < 2.5 mm. Healthy controls exhibited age-appropriate ocular development without eyelid abnormalities.
Key inclusion criteria (1 listed)
- participants aged ≤18 years with compliance during video recording. Congenital ptosis diagnosis mandated documented symptom onset within the first year of life and bilateral or unilateral MRD1 of < 2.5 mm
Key exclusion criteria (1 listed)
- acquired ptosis, myasthenia gravis, Marcus Gunn syndrome, eyelid deformities, or prior ophthalmic surgery
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 |
|---|---|---|
| ptosisno intervention | Other | congenital ptosis |
Primary outcome
levator function testing
Time frame: One-time assessment; results available within 1 week of data collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 41844953Li H, Cao J, Duan S, Hu S, Lou L, Lin M, Jian T, Shao J, Zhang X, Chen P, He Y, Wang J, Huang S, Ye J. From blink to care: smartphone video-based functional analysis and personalized management in pediatric blepharoptosis. NPJ Digit Med. 2026 Mar 18;9(1):358. doi: 10.1038/s41746-026-02510-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Congenital Ptosis, run by Second Affiliated Hospital, Zhejiang 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: finished, as of the sponsor's last update on 22 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levator function testing (time frame: One-time assessment; results available within 1 week of data collection.). 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 NCT07078552, 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 22 Jul 2025.