UMIN-CTR Clinical Trial

Public title

The association between fall, motor vehicle collisions and primary open-angle glaucoma

Acronym

The association between fall, motor vehicle collisions and primary open-angle glaucoma

Scientific Title

The association between fall, motor vehicle collisions and primary open-angle glaucoma

Scientific Title:Acronym

The association between fall, motor vehicle collisions and primary open-angle glaucoma

Region

Japan

Condition

Primary Open-Angle Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The incidence of falls and motor vehicle collisions

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kenya Yuki

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code

Address

Shinanomachi 35,Shinjyuku-ku

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Keio University School of Medicine

Division name

Depaertment of Ophthalmology

Zip code

Address

Shinanomachi 35,Shinjyuku-ku

TEL

Homepage URL

Email

Institute

Keio University School of Medicine,Department of Ophthalmology

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

05

Month

09

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

04

Month

25

Day

Date of IRB

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

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.

Registered date

2011

Year

05

Month

09

Day

Last modified on

2016

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006597