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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043831
Receipt No. R000050023
Scientific Title Screening for keratoconus using Smartphone and artificial intelligence
Date of disclosure of the study information 2021/04/03
Last modified on 2021/04/03

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Basic information
Public title Screening for keratoconus using Smartphone and artificial intelligence
Acronym Screening for keratoconus using Smartphone and artificial intelligence
Scientific Title Screening for keratoconus using Smartphone and artificial intelligence
Scientific Title:Acronym Screening for keratoconus using Smartphone and artificial intelligence
Region
Japan

Condition
Condition Keratoconus
Classification by specialty
Ophthalmology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the possibility for screening of keratoconus by photographs taken with the camera of smartphones and machine learning.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of corneal phtographs by machine learning
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
10 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria Those who are diagnosed to have keratoconus by cornea tomography/topography
Key exclusion criteria Those who reveal other ocular surface diseases or diseases of eye lid, such as severe allergic conjunctivitis, dry eye, corneal dystrophy, entropion, ptosis, and so on.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Tabuchi
Organization Tsukazaki Hospital
Division name Ophthalmology
Zip code 671-1227
Address Waku 68-1, Aboshi-ku, Himeji, Hyogo, Japan
TEL 079-272-8555
Email h.tabuchi@tsukazaki-eye.net

Public contact
Name of contact person
1st name Sachiko
Middle name
Last name Maruoka
Organization Tsukazaki Hospital
Division name Ophthalmology
Zip code 671-1227
Address Waku 68-1, Aboshi-ku, Himeji, Hyogo, Japan
TEL 079-272-8555
Homepage URL
Email s.maruoka@tsukazaki-eye.net

Sponsor
Institute Ophthalmology, Tsukazaki Hospital
Institute
Department

Funding Source
Organization Ophthalmology, Tsukazaki Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tsukazaki Hospital
Address Waku 68-1, Aboshi-ku, Himeji, Hyogo, Japan
Tel 079-272-8555
Email s.maruoka@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 04 Month 03 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
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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 16 Day
Date of IRB
2020 Year 10 Month 20 Day
Anticipated trial start date
2021 Year 04 Month 03 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter study

Management information
Registered date
2021 Year 04 Month 03 Day
Last modified on
2021 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050023

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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