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RecruitingNCT04921020Updated Jun 10, 2021

Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method

An observational study in Eyelid Diseases, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
500
Sex
All
01

Study 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.

02

Conditions studied

  • Eyelid Diseases

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

Exclusion Criteria:

variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil

04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherPhotography

    Facial photographs and blinking videos are taken

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, 5 years

  2. two-dimensional parameters of eyelid topology

    Palpebral fissure area \[Medial area, Corneal area, Lateral area\]

    Time frame: through study completion, 5 years

  3. subtypes of levator function

    Levator function is classified into three categories: good, fair and poor

    Time frame: through study completion, 5 years

06

Study locations

1 of 1 sites recruiting
  • Juan Ye
    Hangzhou, Zhejiang 310000, China
    Recruiting
07

Registry details

Key details

Study ID
NCT04921020
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jun 10, 2021
Start date
Aug 1, 2020
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jun 10, 2021

Study contacts

Juan Ye
Contact
yejuan@zju.edu.cn
+86-571-87783897
Lixia Lou
Contact
loulixia110@zju.edu.cn
+86-15088681589

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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