UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039142 |
|---|---|
| Receipt number | R000044644 |
| Scientific Title | Effective application of optical coherence tomography in glaucoma |
| Date of disclosure of the study information | 2020/01/13 |
| Last modified on | 2020/01/13 23:50:30 |
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Basic information
Public title
Effective application of optical coherence tomography in glaucoma
Acronym
Effective application of OCT in glaucoma
Scientific Title
Effective application of optical coherence tomography in glaucoma
Scientific Title:Acronym
Effective application of OCT in glaucoma
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish methods for effective applications of structure change from OCT in glaucoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
parameters from OCT for early diagnosis of glaucoma and detection of glaucomatous progression
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The objects of this study are glaucoma patients and glacuoma suspects.
Key exclusion criteria
1. When doctor determine an patint ineligible.
2. Ocular fundus is unobservable.
3. Informed consent can not be obtained due to cognitive deterioration.
4. Scheduled examinations can not be performed.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akiyasu |
| Middle name | |
| Last name | Kanamori |
Organization
Kanamori eye clinic
Division name
Ophthalmology
Zip code
6730891
Address
1-6-1, Oakashi-cho, Akashi city
TEL
0789111146
kanaaki@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiyasu |
| Middle name | |
| Last name | Kanamori |
Organization
Kanamori eye clinic
Division name
Ophthalmology
Zip code
6730891
Address
1-6-1, Oakashi-cho, Akashi city
TEL
0789111146
Homepage URL
kanaaki@med.kobe-u.ac.jp
Sponsor or person
Institute
Kanamori eye clinic
Institute
Department
Personal name
Funding Source
Organization
Kanamori eye clinic
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
Kanamori eye clinic
Address
1-6-1, Oakashi-cho, Akashi city
Tel
078911146
kanaaki@med.kobe-u.ac.jp
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
| 2020 | Year | 01 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2020 | Year | 01 | Month | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044644
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
