UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000020143