- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319055
AI-Assisted Facial Surgical Planning
February 16, 2021 updated by: National Taiwan University Hospital
Artificial Intelligence-Assisted Facial, Periocular, and Orbital Analysis and Surgical Planning
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.
Study Overview
Status
Completed
Detailed Description
This auto-diagnosis system of blepharoptosis using machine learning architecture will assist in telemedicine, such as early screening of childhood ptosis for prompt referral and treatment.
People could use this software via mobile devices to get a primitive diagnosis before they reach the physicians.
Furthermore, in primary health care, where there is no oculoplastic surgeon, the software could assist primary care physicians or general ophthalmologists, in identifying the need for a referral.
Study Type
Observational
Enrollment (Actual)
17932
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- National Taiwan University Hospital
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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
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All data was collected at ophthalmic outpatient clinics of National Taiwan University Hospital.
Description
[Inclusion Criteria]
- 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.
[Exclusion Criteria]
- 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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The model performance is evaluated by accuracy
Time Frame: Through study completion, an average of 1 year
|
An Artificial Intelligence Approach
|
Through study completion, an average of 1 year
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AUC (Area Under the Curve)
Time Frame: Through study completion, an average of 1 year
|
An Artificial Intelligence Approach
|
Through study completion, an average of 1 year
|
ROC (Receiver Operating Characteristics) curve.
Time Frame: Through study completion, an average of 1 year
|
An Artificial Intelligence Approach
|
Through study completion, an average of 1 year
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An Artificial Intelligence Approach to Identifying Facial, Periocular, and Orbital Diseases
Time Frame: Through study completion, an average of 1 year
|
The model interpretability is accessed by Grad-CAM (Class Activation Maps).
|
Through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Shu-Lang Liao, MD,MPH, EMBA, National Taiwan University Hospital
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)
January 1, 2009
Primary Completion (ACTUAL)
December 31, 2018
Study Completion (ACTUAL)
July 30, 2019
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
March 23, 2020
First Posted (ACTUAL)
March 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 16, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201908066RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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