UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey of open globe injury in Japan
Title of the study (Brief title)	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	Fumiki Okamoto
Organization	University of Tsukuba
Division name	Department of ophthalmology, Faculty of medicine
Address	1-1-1, Tennoudai, Tsukuba-city, Ibaraki, JAPAN
TEL	029-853-3148
Email	fumiki-o@md.tsukuba.ac.jp

Public contact
Name of contact person	Yoshifumi Okamoto
Organization	University of Tsukuba
Division name	Department of ophthalmology, Faculty of medicine
Address	1-1-1, Tennoudai, Tsukuba-city, Ibaraki, JAPAN
TEL	029-853-3148
Homepage URL
Email	y-okamoto@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026498