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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017356
Receipt No. R000020143
Scientific Title The association of Helicobacter pylori infection in NTG patient
Date of disclosure of the study information 2015/04/30
Last modified on 2019/11/02

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Basic information
Public title The association of Helicobacter pylori infection in NTG patient
Acronym The association of Helicobacter pylori infection in NTG patient
Scientific Title The association of Helicobacter pylori infection in NTG patient
Scientific Title:Acronym The association of Helicobacter pylori infection in NTG patient
Region
Japan

Condition
Condition normal tension glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The association of Helicobacter pylori infection in NTG patient
Basic objectives2 Others
Basic objectives -Others The purpose of this study was to investigate the association between a systemic oxidative stress biomarker, 8-hydroxy-2-deoxyguanosine, and AGE in patients with normal-tension glaucoma and in healthy controls.

Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The association of Helicobacter pylori infection in NTG patient and control group.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
50 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria All subjects with NTG underwent a complete ophthalmic examination, including best corrected visual acuity measurement, slit lamp biomicroscopy, Goldman applanation tonometry, gonioscopy, funduscopy, automated perimetry with the HFA, and optic disc evaluation with a 90-diopter lens by a glaucoma specialist.
Key exclusion criteria Subjects were excluded if they had other ophthalmic conditions, such as angle-closure glaucoma, pigment dispersion glaucoma, exfoliative glaucoma, trauma, any other type of secondary glaucoma, high myopia (exceeding -8D or hyperopia above +3D), or were below 50 or over 60 years of age.
Target sample size 152

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Nakazawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code 980-8574
Address 1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL 0227177294
Email ntoru@oph.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Noriko
Middle name
Last name Himori
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code 980-8574
Address 1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL 0227177294
Homepage URL
Email n-himori@oph.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Department of Ophthalmology
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Medicine
Department of Ophthalmology
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 none
Address none
Tel none
Email none

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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 30 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
2013 Year 09 Month 30 Day
Date of IRB
2013 Year 01 Month 25 Day
Anticipated trial start date
2013 Year 09 Month 30 Day
Last follow-up date
2016 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study of searching

Management information
Registered date
2015 Year 04 Month 30 Day
Last modified on
2019 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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