UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043831 |
|---|---|
| Receipt number | 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 14:16:27 |
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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
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
s.maruoka@tsukazaki-eye.net
Sponsor or person
Institute
Ophthalmology, Tsukazaki Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050023
