NCT04319055

Brief Summary

Computer vision using deep learning architecture is broadly used in auto-recognition. In the research, the deep learning model which is trained by categorized single-eye images is applied to achieve the good performance of the model in blepharoptosis auto-diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17,932

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2009

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

10 years

First QC Date

March 3, 2020

Last Update Submit

February 16, 2021

Conditions

Keywords

Facial Plastic and Reconstructive SurgeryPeriocular DiseasesOrbital DiseasesArtificial Intelligence

Outcome Measures

Primary Outcomes (4)

  • The model performance is evaluated by accuracy

    An Artificial Intelligence Approach

    Through study completion, an average of 1 year

  • AUC (Area Under the Curve)

    An Artificial Intelligence Approach

    Through study completion, an average of 1 year

  • ROC (Receiver Operating Characteristics) curve.

    An Artificial Intelligence Approach

    Through study completion, an average of 1 year

  • An Artificial Intelligence Approach to Identifying Facial, Periocular, and Orbital Diseases

    The model interpretability is accessed by Grad-CAM (Class Activation Maps).

    Through study completion, an average of 1 year

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All data was collected at ophthalmic outpatient clinics of National Taiwan University Hospital.

You may qualify if:

  • The participants who were 20-year-old or above,
  • Surgical informed consent was endorsed by the participants themselves,
  • Participants who have surgical indications of the oculofacial surgeries, and
  • The participants who agreed on photograph taking after explanation by the surgeon at outpatient clinics.

You may not qualify if:

  • The participants who were 19-year-old or under,
  • The participants who don't have surgical indications of the oculofacial surgeries,
  • The participants who were designed for minimal invasive treatments, such as Botox or any kind of fillers injection,
  • The participants who refused photograph taking for any reason, and
  • The participants who are not available for standard quality of photograph taking, such as bedridden patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Orbital Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Shu-Lang Liao, MD,MPH, EMBA

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 24, 2020

Study Start

January 1, 2009

Primary Completion

December 31, 2018

Study Completion

July 30, 2019

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations