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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000034587
Receipt No. R000039429
Scientific Title Diagnostic Evaluation of Keratoconus Using Anterior Segment Optical Coherence Tomography and Machine Learning.
Date of disclosure of the study information 2018/11/01
Last modified on 2019/01/29

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Basic information
Public title Diagnostic Evaluation of Keratoconus Using Anterior Segment Optical Coherence Tomography and Machine Learning.
Acronym Diagnostic Evaluation of Keratoconus Using Machine Learning.
Scientific Title Diagnostic Evaluation of Keratoconus Using Anterior Segment Optical Coherence Tomography and Machine Learning.
Scientific Title:Acronym Diagnostic Evaluation of Keratoconus Using Machine Learning.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the diagnostic power of keratoconus using the anterior segment optical coherence tomography and machine learning.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy
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
60 years-old >
Gender Male and Female
Key inclusion criteria evident findings characteristic of keratoconus (e.g., corneal topography with asymmetric bow-tie pattern with or without skewed axes), and at least one keratoconus sign (e.g., stromal thinning, conical protrusion of the cornea at the apex, Fleischer ring, Vogt striae, or anterior stromal scar) on slit-lamp examination by corneal specialists.
Key exclusion criteria Other corneal diseases or history of corneal surgery
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaztaka Kamiya
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL 0427788464
Email kamiyak-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kamiya Kazutaka
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL 0427788464
Homepage URL
Email kamiyak-tky@umin.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kitasato University, Dept of Ophthalmology
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 11 Month 01 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 Main results already published
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This retrospective study comprised 304 keratoconic eyes and 239 normal eyes with good quality scans of corneal tomography measured with ananterior segment optical coherence tomography.

Management information
Registered date
2018 Year 10 Month 21 Day
Last modified on
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039429

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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