UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018853 |
|---|---|
| Receipt number | R000021764 |
| Scientific Title | Pupil perimetry with colored stimuli in glaucoma |
| Date of disclosure of the study information | 2015/09/10 |
| Last modified on | 2015/09/11 08:47:02 |
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Basic information
Public title
Pupil perimetry with colored stimuli in glaucoma
Acronym
Pupil perimetry with colored stimuli in glaucoma
Scientific Title
Pupil perimetry with colored stimuli in glaucoma
Scientific Title:Acronym
Pupil perimetry with colored stimuli in glaucoma
Region
| Japan |
Condition
Condition
Glaucoma and normal eyes(No history of any disease that may cause visual disorder except for ametropia).
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the sensitivity of glaucomatous visual disorder detection by pupil perimetry with colored stimuli.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the sensitivity and specificity of glaucomatous visual disorder detection by pupil perimetry with colored stimuli.
Index for evaluation is pupillary constriction ratio (magnitude of the light reflex).
Key secondary outcomes
To investigate the normal range of normal eyes of pupil perimetry with colored stimuli.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To measure 100 glaucomatous patients (200 eyes) by a pupil perimetry with colored stimuli.
To measure 100 non-glaucomatous patients by a pupil perimetry with colored stimuli.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Primary open-angle glaucomatous, normal-tension glaucomatous patients and the suspicion.
2. Non-glaucomatous patients ( as a control group). No history of any disease that may cause visual disorder except for ametropia.
3. Subject who can be observed entrance pupil.
4. Subjects who sign an informed consent form to participate in the clinical study.
Key exclusion criteria
1. Eyes that a pupillary scan is difficult due to exfoliation and so on.
2. Disorder of an iris and the autonomic nervous system.
3.History of any disease that may cause visual disorder except for glaucoma (in glaucomatous group).
4. Disorder of the pupil movement due to senile miosis and so on.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Tanzawa |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Sensory Science
Zip code
Address
288, Matsushima, Kurashiki, Okayama
TEL
0864621111
tanzawa@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Tanzawa |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Sensory Science
Zip code
Address
288, Matsushima, Kurashiki, Okayama
TEL
0864621111
Homepage URL
tanzawa@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontrogy
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Saneikai Tsukazaki Hospital
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
三栄会 ツカザキ病院 (兵庫県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 10 | 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
| 2015 | Year | 08 | Month | 30 | Day |
Last modified on
| 2015 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021764
