UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001041 |
|---|---|
| Receipt number | R000001248 |
| Scientific Title | LOWER NORMAL PRESSURE GLAUCOMA STUDY |
| Date of disclosure of the study information | 2008/02/23 |
| Last modified on | 2017/02/27 08:30:22 |
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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
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
reisakata-tky@umin.ac.jp
Sponsor or person
Institute
Japan Glaucoma Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001248
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
