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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04921020
Other study ID # 2020-485
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date August 1, 2026

Study information

Verified date June 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Juan Ye
Phone +86-571-87783897
Email yejuan@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 learning method to extract blinking features, in order to provide new ideas and means to assess eyelid topology and kinetics.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date August 1, 2026
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. normal volunteers without eyelid diseases 2. patients with blepharoptosis 3. patients with blepharospasm 4. patients with dry eye disease 5. patients with Graves' disease Exclusion Criteria: variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Photography
Facial photographs and blinking videos are taken

Locations

Country Name City State
China Juan Ye Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 through study completion, 5 years
Primary two-dimensional parameters of eyelid topology Palpebral fissure area [Medial area, Corneal area, Lateral area] through study completion, 5 years
Primary subtypes of levator function Levator function is classified into three categories: good, fair and poor through study completion, 5 years
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