UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009842
Receipt number R000011534
Scientific Title Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.
Date of disclosure of the study information 2013/01/22
Last modified on 2017/11/26 22:01:00

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Basic information

Public title

Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.

Acronym

Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.

Scientific Title

Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.

Scientific Title:Acronym

Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare the abilities of a conventional perimeter and a perimeter which has a normative database of Japanese population to discriminate between healthy eyes and glaucomatous eyes.

Key secondary outcomes

To investigate the best parameter of a normative database of Japanese population for glaucoma detection in automated perimetry.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Glaucomatous abnormal eye
1) Abnormal glaucomatous appearance of the optic disc on simultaneous stereophotographs.
2) No other intraocular eye disease
3) Spherical refraction is within -6D to +3D. Cylinder correction is within -2.5D to +2.5D.
4) Corrected visual acuity >= 0.9
5) Subjects who agree to the participation in this study.
Normal eye
1) Normal optic disc on simultaneous stereophotographs.
2) No any intraocular eye disease
3) IOP <= 20 mmHg
4) Spherical refraction is within -6D to +3D. Cylinder correction is within -2.5D to +2.5D.
5) Corrected visual acuity >= 0.9
6) Subjects who agree to the participation in this study.

Key exclusion criteria

Glaucomatous abnormal eye
1) History of disease which affect the visual field sensitivity except glaucoma.
2) History of intraocular surgery.
3) History of medications which affect visual field sensitivity.
Normal eye
1) History of disease which affect the visual field sensitivity.
2) History of intraocular surgery.
3) History of medications which affect visual field sensitivity.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhisa Sugiyama

Organization

Kanazawa University

Division name

Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences

Zip code


Address

13-1 Takara-machi, Kanazawa city, Ishikawa Pref.

TEL

076-265-2403

Email

eyeshin@med.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinji Ohkubo

Organization

Kanazawa University

Division name

Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences

Zip code


Address

13-1 Takara-machi, Kanazawa city, Ishikawa Pref.

TEL

076-265-2403

Homepage URL


Email

eyeshin@med.kanazawa-u.ac.jp


Sponsor or person

Institute

Kanazawa University
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences

Institute

Department

Personal name



Funding Source

Organization

Kowa company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kinki University Faculty of Medicine / Department of Ophthalmology
Tajimi Iwase Eye Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

金沢大学付属病院(石川県)
近畿大学医学部附属病院(大阪府)
たじみ岩瀬眼科(岐阜県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2012 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2013 Year 08 Month 30 Day

Date analysis concluded



Other

Other related information

Sensitivity and Specificity.


Management information

Registered date

2013 Year 01 Month 22 Day

Last modified on

2017 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011534


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name