UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022381 |
|---|---|
| Receipt number | R000025794 |
| Scientific Title | Investigation of fixation behavior in visual field measurement |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2016/11/21 09:36:11 |
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Basic information
Public title
Investigation of fixation behavior in visual field measurement
Acronym
Fixation behavior in visual field measurement
Scientific Title
Investigation of fixation behavior in visual field measurement
Scientific Title:Acronym
Fixation behavior in visual field measurement
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the fixation behavior during visual field measurement in early to severe glaucoma patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between variability of sensitivity and fixation behavior.
Construction of new reliability criteria based on fixation behavior.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who had visual field measurement at least three times.
The patients who had spherical refraction -8 diopter to +3 diopter.
The patients who had astigmatic refraction less than -1.5 diopter
Key exclusion criteria
The patients who had unreliability result with Humphrey Field Analyzer (more than 20% of fixation loss and 15% of false positive rate)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori HIRASAWA |
Organization
School of Allied Health Sciences, KITASATO University.
Division name
Department of Orthoptic and Visual Science
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN
TEL
+81427789671
hirasawa@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Hirasawa |
Organization
School of Allied Health Sciences, Kitasato University
Division name
Department of Orthoptic and Visual Science
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN
TEL
0427789671
Homepage URL
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | 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
prospective study
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2016 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025794
