UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011311 |
|---|---|
| Receipt number | R000013252 |
| Scientific Title | The learning effect and repeatability of automated kinetic perimetry in healthy participants |
| Date of disclosure of the study information | 2013/07/30 |
| Last modified on | 2015/07/23 09:58:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The learning effect and repeatability of automated kinetic perimetry in healthy participants
Acronym
The learning effect and repeatability of automated kinetic perimetry
Scientific Title
The learning effect and repeatability of automated kinetic perimetry in healthy participants
Scientific Title:Acronym
The learning effect and repeatability of automated kinetic perimetry
Region
| Japan |
Condition
Condition
health participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the learning effect and repeatability of automated kinetic perimetry in the inexperienced and experienced healthy youner participants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
kinetic sensitivity
test duration
variability (MS, CoV)
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The automated kinetic perimetry are performed with inexperienced group three times.The first and second measurements are performed on the same day, and the third measurement was performed another day.
Interventions/Control_2
The automated kinetic perimetry are performed with experienced group three times.The first and second measurements are performed on the same day, and the third measurement was performed another day.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants who had best-corrected visual acuity of 20/20 or better; intraocular pressure of 21 mm Hg or less; and the normal appearance of the fundus were underwent the automated kinetic perimetry.
Key exclusion criteria
Fixation loss recognized on the display.
A lack of fit for corrective contact lenses.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shoji |
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
042-778-8464
nshoji@ahs.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
042-778-8464
Homepage URL
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Graduate school of medical science, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Graduate school of medical science, Kitasato University
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 30 | 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
| 2011 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
Management information
Registered date
| 2013 | Year | 07 | Month | 30 | 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=R000013252
