UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic Evaluation of Keratoconus Using Corneal Topography and Machine Learning.
Acronym	Diagnostic Evaluation of Keratoconus Using Machine Learning.
Scientific Title	Diagnostic Evaluation of Keratoconus Using Corneal Topography 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 corneal topography 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	250

Research contact person
Name of lead principal investigator	1st name Kazutaka Middle name Last name Kamiya
Organization	Kitasato University
Division name	School of Allied Health Sciences
Zip code	2520373
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	1st name Kazutaka Middle name Last name Kamiya
Organization	Kitasato University
Division name	School of Allied Health Sciences
Zip code	2520373
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

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

IRB Contact (For public release)
Organization	Kitasato University
Address	1-15-1 Kitasato, Minami, Sagamihara, Kitasato
Tel	0427788464
Email	kamiyak-tky@umin.ac.jp

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	2020 Year 04 Month 10 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	271
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	2019 Year 01 Month 01 Day
Date of IRB	2020 Year 04 Month 10 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This retrospective study comprised 153 keratoconic eyes and 118 normal eyes with good quality scans of corneal tomography measured with corneal topography.

Management information
Registered date	2020 Year 04 Month 10 Day
Last modified on	2020 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045757