UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013248 |
|---|---|
| Receipt number | R000015459 |
| Scientific Title | Evaluation of axial length requiring adjustment for ocular magnification in circumpapirally retinal nerve fiber layer measurement |
| Date of disclosure of the study information | 2014/02/24 |
| Last modified on | 2015/07/23 10:01:20 |
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Basic information
Public title
Evaluation of axial length requiring adjustment for ocular magnification in circumpapirally retinal nerve fiber layer measurement
Acronym
Evaluation of axial length requiring adjustment for ocular magnification
Scientific Title
Evaluation of axial length requiring adjustment for ocular magnification in circumpapirally retinal nerve fiber layer measurement
Scientific Title:Acronym
Evaluation of axial length requiring adjustment for ocular magnification
Region
| Japan |
Condition
Condition
healthy young participants
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the axial length requiring adjustment for ocular magnification in circumpapillary retinal nerve fiber layer (cpRNFL) measurement with spectral domain optical coherence tomography (OCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement error value
correlation between axial length and cpRNFL thickness
cut-off value for axial length requiring adjustment for ocular magnification
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
control group which the difference of total cpRNFL thickness with and without adjustment was within the range of the measurement error.
Interventions/Control_2
thinner group which total cpRNFL thickness with adjustment was thinner than that without adjustment
Interventions/Control_3
thicker group which total cpRNFL thickness with adjustment was thicker than that without adjustment.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants who had a corrected visual acuity of 20/20 or better, intraocular pressure of 21 mmHg or less, a normal optic disc, and no funds diseases were included.
Key exclusion criteria
Imaging results, which had image quality of 70 or less and the lack or deviation of OCT line images after examination, were excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Hirasawa |
Organization
Graduate school of Medical Science, Kitasato University
Division name
Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan
TEL
+81-42-778-8464
hirasawa@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Hirasawa |
Organization
Graduate school of Medical Science, Kitasato University
Division name
Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan.
TEL
+81-42-778-8464
Homepage URL
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Allied Health Science
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
北里大学医療衛生学部（神奈川）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 24 | Day |
Last modified on
| 2015 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015459
