UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033372 |
|---|---|
| Receipt number | R000038044 |
| Scientific Title | Prediction of spectacle-corrected visual acuity of keratoconus eye using anterior eye OCT |
| Date of disclosure of the study information | 2018/07/12 |
| Last modified on | 2018/07/12 10:36:44 |
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Basic information
Public title
Prediction of spectacle-corrected visual acuity of keratoconus eye using anterior eye OCT
Acronym
Prediction of spectacle-corrected visual acuity of keratoconus eye using anterior eye OCT
Scientific Title
Prediction of spectacle-corrected visual acuity of keratoconus eye using anterior eye OCT
Scientific Title:Acronym
Prediction of spectacle-corrected visual acuity of keratoconus eye using anterior eye OCT
Region
| Japan |
Condition
Condition
Keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To predict potential spectacle-corrected visual acuity of keratoconus patient's corneal shape.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity of keratoconus eye will be predicted by the anterior eye OCT(optical coherence tomography, OCT)parameter. Multiple regression analysis will be used for statistical analysis method, spectacle-corrected visual acuity is for dependent variable, anterior eye OCT parameter is for explanatory variable to analyze. Prediction accuracy will be assessed in other group.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with anterior OCT test result and diagnosed as keratoconus by corneal specialist.
Key exclusion criteria
Patient with other eye disease which may affect visual acuity (cataract, glaucoma, diabetic retinopathy, etc.), or patient with weak eyesight.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuri Esaka |
Organization
JCHO Chukyo Hospital
Division name
Opthalmology
Zip code
Address
1-1-10 Sanjo Minami-ku, Nagoya, Aichi
TEL
0120-758-0490
esaka@chukyogroup.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Color Vision Research Institute
Zip code
Address
12-22 Sanbonmatsu, Atsuta-ku, Nagoya-shi, Aichi
TEL
052-884-7976
Homepage URL
ichikawa@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
non
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
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
岐阜赤十字病院（岐阜県）、名古屋アイクリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | 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
Visual acuity of keratoconus eye will be predicted by the anterior eye OCT(optical coherence tomography, OCT)parameter. Multiple regression analysis will be used for statistical analysis method, spectacle-corrected visual acuity is for dependent variable, anterior eye OCT parameter is for explanatory variable to analyze. Prediction accuracy will be assessed in other group.
Management information
Registered date
| 2018 | Year | 07 | Month | 12 | Day |
Last modified on
| 2018 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038044
