UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.
Title of the study (Brief title)	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	Kazuhisa Sugiyama
Organization	Kanazawa University
Division name	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
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	Shinji Ohkubo
Organization	Kanazawa University
Division name	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Address	13-1 Takara-machi, Kanazawa city, Ishikawa Pref.
TEL	076-265-2403
Homepage URL
Email	eyeshin@med.kanazawa-u.ac.jp

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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011534