- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04921020
Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method
June 8, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juan Ye
- Phone Number: +86-571-87783897
- Email: yejuan@zju.edu.cn
Study Contact Backup
- Name: Lixia Lou
- Phone Number: +86-15088681589
- Email: loulixia110@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Juan Ye
-
Contact:
- Juan Ye
- Phone Number: +86-571-87783897
- Email: yejuan@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- normal volunteers without eyelid diseases
- patients with blepharoptosis
- patients with blepharospasm
- patients with dry eye disease
- patients with Graves' disease
Exclusion Criteria:
variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normal participants
|
Facial photographs and blinking videos are taken
|
Patients with blepharoptosis
|
Facial photographs and blinking videos are taken
|
Patients with blepharospasm
|
Facial photographs and blinking videos are taken
|
Patients with dry eye disease
|
Facial photographs and blinking videos are taken
|
Patients with Graves' disease
|
Facial photographs and blinking videos are taken
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, 5 years
|
two-dimensional parameters of eyelid topology
Time Frame: through study completion, 5 years
|
Palpebral fissure area [Medial area, Corneal area, Lateral area]
|
through study completion, 5 years
|
subtypes of levator function
Time Frame: through study completion, 5 years
|
Levator function is classified into three categories: good, fair and poor
|
through study completion, 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Anticipated)
August 1, 2025
Study Completion (Anticipated)
August 1, 2026
Study Registration Dates
First Submitted
June 1, 2021
First Submitted That Met QC Criteria
June 8, 2021
First Posted (Actual)
June 10, 2021
Study Record Updates
Last Update Posted (Actual)
June 10, 2021
Last Update Submitted That Met QC Criteria
June 8, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-485
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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