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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026200
Receipt No. R000029840
Scientific Title 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
Date of disclosure of the study information 2017/03/01
Last modified on 2019/02/19

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Basic information
Public title 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
Acronym Examination of consistency between the borderline of nasal step and temporal raphe
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Takuji Kurimoto
Organization Kobe University Graduate School of Medicine
Division name Ophthalmology
Zip code
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
1st name
Middle name
Last name Takuji Kurimoto
Organization Kobe University Graduate School of Medicine
Division name Ophthalmology
Zip code
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)

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
2017 Year 03 Month 01 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
2017 Year 03 Month 01 Day
Date of IRB
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

Other
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

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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