UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034587 |
|---|---|
| Receipt number | 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 09:10:43 |
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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
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
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039429
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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