UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022559 |
|---|---|
| Receipt number | R000025997 |
| Scientific Title | Evaluation of visual function in glaucoma |
| Date of disclosure of the study information | 2016/05/31 |
| Last modified on | 2016/05/31 20:32:55 |
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Basic information
Public title
Evaluation of visual function in glaucoma
Acronym
Evaluation of visual function in glaucoma
Scientific Title
Evaluation of visual function in glaucoma
Scientific Title:Acronym
Evaluation of visual function in glaucoma
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence that visual field loss gives to the daily visual function in glaucoma patients using functional visual acuity
Basic objectives2
Others
Basic objectives -Others
Evaluation of visual performance
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of visual acuity, functional visual acuity and perimetry
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with 20/20 vision or more
2) Patients conducted high reliable examination measured by the Humphrey Visual Field Testing Instrument
Key exclusion criteria
1) Patients with disorder affected functional visual acuity
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Tasaka |
Organization
Minami-matsuyama Hospital
Division name
Ophthalmology
Zip code
Address
1-3-10 Asoda-cho, Matsuyama, Ehime
TEL
089-941-8255
tasaka@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Kamao |
Organization
Ehime University
Division name
Ophthalmology
Zip code
Address
Shitsukawa, Ton-city, Ehime
TEL
089-960-5361
Homepage URL
t-kamao@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
南松山病院（愛媛県） Minami-matsuyama Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 31 | 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
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
case series
All patients were examined who meet the selection criteria at Minami-matsuyama Hospital from February 2015 to March 2015.
To compare visual acuity, functional visual acuity and perimetry of paracentral scotoma, non-paracentral scotoma and control group.
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2016 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025997
