UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The association between fall, motor vehicle collisions and primary open-angle glaucoma
Title of the study (Brief title)	The association between fall, motor vehicle collisions and primary open-angle glaucoma
Region	Japan

Condition
Condition	Primary Open-Angle Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate and compare the incidence of motor vehicle collisions and falls involving individuals with or without primary open-angle glaucoma.
Basic objectives2	Others
Basic objectives -Others	To investigate and compare the incidence of motor vehicle collisions and falls involving individuals with or without primary open-angle glaucoma.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of falls and motor vehicle collisions
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects were screened for eligibility by means of an ophthalmic examination that included slit-lamp biomicroscopy, funduscopy, gonioscopy, intraocular pressure measurements with Goldmann applanation tonometry, and visual field examination with a static visual field analyzer using the 30-2 Swedish Interactive Threshold Algorithm Standard Strategy (Carl Zeiss Meditec, Dublin, CA) when necessary. POAG was diagnosed on the basis of the presence of the following 3 findings: (1) glaucomatous optic cupping represented by notch formation, generalized enlargement of cupping, senile sclerotic disc or myopic disc, or nerve fiber layer defects; (2) typical glaucomatous visual field defects such as Bjerrum scotoma, nasal step, or paracentral scotoma compatible with optic disc appearance; and (3) open and not occludable angle observed on gonioscopy. All patients with POAG underwent a visual field examination to assess POAG severity. For the purposes of this study, we defined mild POAG as a visual field defect corresponding to a mean deviation (MD) of -6 dB or better in both eyes, moderate POAG as corresponding to a MD of -6 to -12 dB in the worse eye, and severe POAG as a MD of -12 dB or worse in the worse eye.
Key exclusion criteria	Subjects with fundus disease such as age-related macular degeneration, prpriferative diabetic retinopathy, or any fundus diease. Subjects who is unable to take informed consent. Subjects who cannot walk without help.
Target sample size	800

Research contact person
Name of lead principal investigator	Kenya Yuki
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	Shinanomachi 35,Shinjyuku-ku
TEL
Email

Public contact
Name of contact person
Organization	Keio University School of Medicine
Division name	Depaertment of Ophthalmology
Address	Shinanomachi 35,Shinjyuku-ku
TEL
Homepage URL
Email

Sponsor
Institute	Keio University School of Medicine,Department of Ophthalmology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 25 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry	2015 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	This study is a cross-sectional and prospective cohort study. All participants were requested to answer a questionnaire that elicited information on,in breif whether they had been involved in one or more MVCs over the past five years while driving, whether they had fallen once or more over the past one years; current daily driving habits, number of years since acquisition of first driving license, current illnesses and medical history, and demographic characteristics, age, sex. Patients were excluded from the study if they had never held a driver license, and or they had any mental disease. These data were compared between control and POAG group. Same questionnaire were followed annually by mail of telephone for five years.

Management information
Registered date	2011 Year 05 Month 09 Day
Last modified on	2016 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006597