UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026200 |
|---|---|
| Receipt number | 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 13:44:32 |
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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
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
kuri1201@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029840
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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