UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of consistency between the borderline of nasal step obtained from the analysis of nasal step with microperimeter and temporal raphe detected by optical coherence tomography
Title of the study (Brief title)	Examination of consistency between the borderline of nasal step and temporal raphe
Region	Japan

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

Objectives
Narrative objectives1	We will perform the visual field test and fundus tomography using MP-3 and spectral domain OCT (Spectralis) on glaucoma patients in the Department of Ophthalmology, Kobe University Hospital. The aim of the present study is to reveal the degree to which disc-fovea-raphe (DFR) angle, determined by the nasal step boundary on the MP-3 perimetry customized program and DFR obtained from OCT agree with each other. If the present study reveals that the DFR angle determined by the two modality agree well, it will serve as the rationale that MP-3, which is less expensive and time-consuming for data acquisition and analysis compared with the temporal raphe delineation by OCT, may be the alternative approach to find the nasal step and thus the functional temporal raphe.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disc-fovea-raphe angle
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	MP-3 and Spectralis OCT The number of intervention is twice. The second test will be performed within six months after the first test.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Inclusion criteria Subjects should fulfill all conditions as follows: 1) Patients with ages ranging from 20 and 80 years when informed consent is obtained, and visit our department at least every three month. 2) Visual field defect with the Humphrey visual field mean deviation ranging from -2dB and -15dB and confined to either the upper or lower hemifield 3) Written informed consent with free will is obtained.
Key exclusion criteria	Exclusion criteria Patients who have at least one condition as below will be excluded. 1) Intraocular diseases except for incipient cataract, pseudophakia, glaucoma. 2) Intraocular surgery within a month before the enrollment 3) Poor fixation 4) Those who can not keep an appropriate posture during examinations 5) Those whom attending doctors judge inappropriate for the entry of the present study
Target sample size	40

Research contact person
Name of lead principal investigator	Takuji Kurimoto
Organization	Kobe University Graduate School of Medicine
Division name	Ophthalmology
Address	7-5-2 Kusunoki-cho Chuo-ku Kobe
TEL	078-382-5111
Email	kuri1201@med.kobe-u.ac.jp

Public contact
Name of contact person	Takuji Kurimoto
Organization	Kobe University Graduate School of Medicine
Division name	Ophthalmology
Address	7-5-2 Kusunoki-cho Chuo-ku Kobe
TEL	078-382-5111
Homepage URL
Email	kuri1201@med.kobe-u.ac.jp

Sponsor
Institute	Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2017 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2018 Year 08 Month 30 Day
Date of closure to data entry	2018 Year 10 Month 01 Day
Date trial data considered complete	2018 Year 10 Month 15 Day
Date analysis concluded	2018 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 17 Day
Last modified on	2019 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029840