NCT04921020

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Aug 2020Aug 2026

Study Start

First participant enrolled

August 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

June 1, 2021

Last Update Submit

June 8, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • two-dimensional parameters of eyelid topology

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

    through study completion, 5 years

  • subtypes of levator function

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

    through study completion, 5 years

Study Arms (5)

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

Facial photographs and blinking videos are taken

Normal participantsPatients with Graves' diseasePatients with blepharoptosisPatients with blepharospasmPatients with dry eye disease

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • normal volunteers without eyelid diseases
  • patients with blepharoptosis
  • patients with blepharospasm
  • patients with dry eye disease
  • patients with Graves' disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Ye

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Eyelid Diseases

Interventions

Photography

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 10, 2021

Study Start

August 1, 2020

Primary Completion

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations