UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037951
Receipt number R000043260
Scientific Title Detectability of glaucoma using FDT perimetry in comprehensive health checkup service.
Date of disclosure of the study information 2019/09/06
Last modified on 2019/09/06 13:22:19

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Basic information

Public title

Effectiveness of frequency doubling technology perimetry in glaucoma screening.

Acronym

Effectiveness of frequency doubling technology

Scientific Title

Detectability of glaucoma using FDT perimetry in comprehensive health checkup service.

Scientific Title:Acronym

Glaucoma screening using FDT perimetry

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of frequency doubling technology perimetry (FDT) on detectability of glaucoma in comprehensive health checkup service.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection rate of glaucoma

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

all subjects undergoing comprehensive medical checkup service.

Key exclusion criteria

glaucoma patients

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Ryo
Middle name
Last name Terauchi

Organization

The Jikei University School of Medicine

Division name

Department of Ophthalmology

Zip code

105-8461

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo, 105-8461, Japan

TEL

03-3433-1111

Email

r.terauchi0813@gmail.com


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Terauchi

Organization

The Jikei University School of Medicine

Division name

Department of Ophthalmology

Zip code

105-8461

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo, 105-8461, Japan

TEL

03-3433-1111

Homepage URL


Email

h19ms-terauchi@jikei.ac.jp


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Non

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Jikei University School of Medicine

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo, 105-8461, Japan

Tel

03-3433-1111

Email

h19ms-terauchi@jikei.ac.jp


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

2019 Year 09 Month 06 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

3000

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

2018 Year 04 Month 01 Day

Date of IRB

2018 Year 12 Month 26 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2020 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Non


Management information

Registered date

2019 Year 09 Month 06 Day

Last modified on

2019 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043260


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name