UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	LOWER NORMAL PRESSURE GLAUCOMA STUDY
Title of the study (Brief title)	LNPGS
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clear up many clinical features in the Normal Pressure Glaucoma (NPG) patients (intraocular pressure is less than 15 mmHg) during the time course. To examine the eye-specific and systemic risk factors regarding about the visual field progression. The prospective study (about 165 patients and three observation years) in domestic multi facilities.
Basic objectives2	Others
Basic objectives -Others	Observasional study
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Progression of visual field defect and/or optic disc damage
Key secondary outcomes	Campimetry results with Humphrey automated perimeter,disc hemorrhage and parameter of HRT II and GDx VCC

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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Primary open-angle glaucoma patients to fullfill the following criterias. The intraocular pressure (IOP) lowering drugs are not used or after four weeks or more have passed since the IOP drugs were discontinued, the IOP is 15 mmHg or less excluding one measurement at five times or more measured on different days within six months. The tonometry mesurements should be always less than 21 mmHg. The level of visual field defect: MD of both eyes is more excellent than that of -15 dB.
Key exclusion criteria	An equivalent sphered value is -9.0D less than or +9.0D or more. Best corrected visual acuity is less than 0.8. Anamnestic history of any eye surgerys including laser therapy. Eyes with cataract that influences the visual field. The patinets who have taken orally hypotensive agents or agents about protection of tissue damege. The patinets who have troubles such as hepertension (over 160/90) and diabetes mellitus.
Target sample size	165

Research contact person
Name of lead principal investigator	Araie Makoto
Organization	Director, Kanto Central Hospital
Division name	Department of Ophthalmology
Address	6-25-1, Kamiyouga, Setagaya-ku, 158-8531, Tokyo, Japan
TEL	03-3429-1171
Email	araie-tky@umin.net

Public contact
Name of contact person	Sakata Rei
Organization	The University of Tokyo Hospital
Division name	Department of Ophthalmology
Address	7-3-1 Hongo, Bunkyoku, Tokyo, 113-8655 Japan
TEL	03-3815-5411
Homepage URL
Email	reisakata-tky@umin.ac.jp

Sponsor
Institute	Japan Glaucoma Society
Institute
Department

Funding Source
Organization	Japan Glaucoma Society
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	2008 Year 02 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 10 Month 13 Day
Anticipated trial start date	2007 Year 11 Month 01 Day
Last follow-up date	2015 Year 12 Month 01 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded	2018 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective study of background factors for normal tension glaucoma patinets.

Management information
Registered date	2008 Year 02 Month 19 Day
Last modified on	2017 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001248