UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001041
Receipt No. R000001248
Scientific Title LOWER NORMAL PRESSURE GLAUCOMA STUDY
Date of disclosure of the study information 2008/02/23
Last modified on 2017/02/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title LOWER NORMAL PRESSURE GLAUCOMA STUDY
Acronym LNPGS
Scientific Title LOWER NORMAL PRESSURE GLAUCOMA STUDY
Scientific Title:Acronym 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
1st name
Middle name
Last name Araie Makoto
Organization Director, Kanto Central Hospital
Division name Department of Ophthalmology
Zip code
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
1st name
Middle name
Last name Sakata Rei
Organization The University of Tokyo Hospital
Division name Department of Ophthalmology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2008 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2007 Year 10 Month 13 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000001248

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.