UMIN-CTR Clinical Trial

Basic information
Public title	Developing an iOS application that uses machine learning for the automated diagnosis of blepharoptosis
Acronym	automated diagnosis of blepharoptosis
Scientific Title	Developing an iOS application that uses machine learning for the automated diagnosis of blepharoptosis
Scientific Title:Acronym	automated diagnosis of blepharoptosis
Region	Japan

Condition
Condition	blepharoptosis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the performance of artificial intelligence in the automated classification of images taken with a tablet device of blepharoptosis patients and subjects with normal eyelid.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity , Specificity
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	blepharoptosis
Key exclusion criteria	Trauma
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Nagasato
Organization	Tsukazaki Hospital
Division name	Ophthalmology
Zip code	671-1227
Address	68-1 Waku Aboshiku Himeji City
TEL	0792728555
Email	d.nagasato@tsukazaki-eye.net

Public contact
Name of contact person	1st name Daisuke Middle name Last name Nagasato
Organization	Tsukazaki Hospital
Division name	Ophthalmology
Zip code	671-1227
Address	68-1 Waku Aboshiku Himeji City
TEL	0792728555
Homepage URL
Email	d.nagasato@tsukazaki-eye.net

Sponsor
Institute	Tsukazaki Hospital
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tsukazaki Hospital
Address	68-1 Waku Aboshiku Himeji City
Tel	0792728555
Email	d.nagasato@tsukazaki-eye.net

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	606
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 01 Day
Date of IRB	2017 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 10 Month 18 Day
Last follow-up date	2021 Year 01 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	non

Management information
Registered date	2021 Year 06 Month 25 Day
Last modified on	2021 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051004