UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022685 |
|---|---|
| Receipt number | R000026144 |
| Scientific Title | Binocular vision and QOL for glaucomatous visual field defect |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2021/01/03 15:00:17 |
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Basic information
Public title
Binocular vision and QOL for glaucomatous visual field defect
Acronym
Binocular vision and QOL for glaucoma
Scientific Title
Binocular vision and QOL for glaucomatous visual field defect
Scientific Title:Acronym
Binocular vision and QOL for glaucoma
Region
| Japan |
Condition
Condition
primary open angle glaucoma,Normal people
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the relationship glaucomatous visual field defect,binocular vision and Quality of Life
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship glaucomatous visual field defect and Binocular Vision and Quality of Life
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
(1) Written informed consent: Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients.
(2) Patients aged 20 years or older who are capable of providing consent.
(3) Males and females.
(4)Primary open angle glaucoma
(5)Normal people
Key exclusion criteria
1) History of disease which affect the visual field sensitivity except glaucoma.
2) Patients with history of refractive surgery, vitreous surgery or retinal detachment surgery.
3)Strabismus
4)History of amblyopia (annisometropic amblyopia and refractive amblyopia)
5) Unable to perform visual field test.
6) Patients whom doctor judged to be ineligible for this study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Sugiyama |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2000
ganjimu2@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Udagawa |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2000
Homepage URL
s-uda@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tajimi Iwase eye clinic: Aiko Iwase
Ohkubo eye clinic: Shinji Ohkubo
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 | 06 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Visual field defect
Binocular vision
Quality of Life
Management information
Registered date
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2021 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026144
