Eyelid DiseasesNCT04921020
Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method
An observational study of Eyelid Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study plans to assess eyelid topology (such as margin reflex distance, eyelid contour, and corneal exposure area) and blinking (such as frequency, velocity, and duration), using deep learning method to automatically extract eyelid topological features, and to predict subtypes of levator function, using deep… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Eyelid Diseases
- What is being tested?
- Photography
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Aug 2026
- 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: 100 normal volunteers without eyelid diseases 100 patients with blepharoptosis 100 patients with blepharospasm 100 patients with dry eye disease 100 patients with Graves' disease
Who may be able to join
- normal volunteers without eyelid diseases
- patients with blepharoptosis
- patients with blepharospasm
- patients with dry eye disease
- patients with Graves' disease
Who cannot join
- variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Juan Ye
Hangzhou, Zhejiang, 310000
Juan Ye, +86-571-87783897, yejuan@zju.edu.cn
About this study
Official title: Department of Ophthalmology
This study plans to assess eyelid topology (such as margin reflex distance, eyelid contour, and corneal exposure area) and blinking (such as frequency, velocity, and duration), using deep learning method to automatically extract eyelid topological features, and to predict subtypes of levator function, using deep learning method to extract blinking features, in order to provide new ideas and means to assess eyelid topology and kinetics.
- Conditions
- Eyelid Diseases
- Being tested
- Photography
- Medical subject headings
- Eyelid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotographyOther
Facial photographs and blinking videos are taken
| Study group | Role | What they receive |
|---|---|---|
| Normal participants | Not described Receives: Other: Photography | |
| Patients with blepharoptosis | Not described Receives: Other: Photography | |
| Patients with blepharospasm | Not described Receives: Other: Photography | |
| Patients with dry eye disease | Not described Receives: Other: Photography | |
| Patients with Graves' disease | Not described Receives: Other: Photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-dimensional parameters of eyelid topology
Palpebral fissure length [Margin reflex distance 1, Margin reflex distance 2], Lid length [Upper lid length, Lower lid length], Multiple mid-pupil lid distances
Measured: through study completion, 5 years
two-dimensional parameters of eyelid topology
Palpebral fissure area [Medial area, Corneal area, Lateral area]
Measured: through study completion, 5 years
subtypes of levator function
Levator function is classified into three categories: good, fair and poor
Measured: through study completion, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921020
- Sponsor's protocol ID
- 2020-485
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 10 Jun 2021
- 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 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Ophthalmology
- ClinicalTrials.gov ID
- NCT04921020
- Acronym / sponsor ID
- 2020-485
- Conditions
- Eyelid Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 10 Jun 2021 (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 plans to assess eyelid topology (such as margin reflex distance, eyelid contour, and corneal exposure area) and blinking (such as frequency, velocity, and duration), using deep learning method to automatically extract eyelid topological features, and to predict subtypes of levator function, using deep learning method to extract blinking features, in order to provide new ideas and means to assess eyelid topology and kinetics.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal participants | – | Other: Photography |
| Patients with blepharoptosis | – | Other: Photography |
| Patients with blepharospasm | – | Other: Photography |
| Patients with dry eye disease | – | Other: Photography |
| Patients with Graves' disease | – | Other: Photography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 normal volunteers without eyelid diseases 100 patients with blepharoptosis 100 patients with blepharospasm 100 patients with dry eye disease 100 patients with Graves' disease
Key inclusion criteria (5 listed)
- normal volunteers without eyelid diseases
- patients with blepharoptosis
- patients with blepharospasm
- patients with dry eye disease
- patients with Graves' disease
Key exclusion criteria (1 listed)
- variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil
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 |
|---|---|---|
| PhotographyFacial photographs and blinking videos are taken | Other | Normal participants, Patients with Graves' disease, Patients with blepharoptosis, Patients with blepharospasm, Patients with dry eye disease |
Primary outcome
one-dimensional parameters of eyelid topology
Time frame: through study completion, 5 years
Palpebral fissure length [Margin reflex distance 1, Margin reflex distance 2], Lid length [Upper lid length, Lower lid length], Multiple mid-pupil lid distances
two-dimensional parameters of eyelid topology
Time frame: through study completion, 5 years
Palpebral fissure area [Medial area, Corneal area, Lateral area]
subtypes of levator function
Time frame: through study completion, 5 years
Levator function is classified into three categories: good, fair and poor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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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 Eyelid Diseases, 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 5 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 10 Jun 2021. 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 Juan Ye (+86-571-87783897, yejuan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-dimensional parameters of eyelid topology (time frame: through study completion, 5 years). The study lists 3 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 10 Jun 2021.