UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022997 |
|---|---|
| Receipt number | R000026498 |
| Scientific Title | Survey of open globe injury in Japan |
| Date of disclosure of the study information | 2016/07/07 |
| Last modified on | 2019/01/07 22:21:26 |
* 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
Survey of open globe injury in Japan
Acronym
Survey of open globe injury in Japan
Scientific Title
Survey of open globe injury in Japan
Scientific Title:Acronym
Survey of open globe injury in Japan
Region
| Japan |
Condition
Condition
open globe injury
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate mechanism of injury, visual acuity at final visit, and operative procedure in Japanese patients with open globe injury.
Basic objectives2
Others
Basic objectives -Others
To investigate the factors associated with visual prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity at final visit
Key secondary outcomes
mechanism of injury
operative procedure
preoperative visual acuity
location of perforating wound
cause of reduced vision
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
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients described main outcome measure
Key exclusion criteria
Patients undescribed main outcome measure
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiki Okamoto |
Organization
University of Tsukuba
Division name
Department of ophthalmology, Faculty of medicine
Zip code
Address
1-1-1, Tennoudai, Tsukuba-city, Ibaraki, JAPAN
TEL
029-853-3148
fumiki-o@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Okamoto |
Organization
University of Tsukuba
Division name
Department of ophthalmology, Faculty of medicine
Zip code
Address
1-1-1, Tennoudai, Tsukuba-city, Ibaraki, JAPAN
TEL
029-853-3148
Homepage URL
y-okamoto@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
J-CREST
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
筑波大学附属病院水戸地域医療教育センター・水戸協同病院（茨城県）、新潟大学医歯学総合病院眼科（新潟県）、滋賀医科大学医学部附属病院眼科（滋賀県）、福井大学医学部附属病院眼科（福井県）、市立札幌病院眼科（北海道）、東京医科大学八王子医療センター眼科（東京都）、奈良県立医科大学附属病院眼科（奈良県）、名古屋市立大学病院眼科（愛知県）、徳島大学病院眼科（徳島県）、鹿児島大学病院眼科（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In each hospital, observational period was defined
as long as trailable. In Tsukuba university hospital, defined from Sep 2003 to Nov 2015.
Management information
Registered date
| 2016 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026498
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
