UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018091 |
|---|---|
| Receipt number | R000020940 |
| Scientific Title | Functional and morphological change by OCT angiography after macular surgery |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2015/06/25 18:27:14 |
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Basic information
Public title
Functional and morphological change by OCT angiography after macular surgery
Acronym
Evaluation by OCT angiography after macular surgery
Scientific Title
Functional and morphological change by OCT angiography after macular surgery
Scientific Title:Acronym
Evaluation by OCT angiography after macular surgery
Region
| Japan |
Condition
Condition
macular hole, epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the morphological change of macular vessels and retinal function after surgeries for macular disorders
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
vascular changes at macular
Key secondary outcomes
retinal sensitivity, best-corrected visual acuity
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cases with macular hole or epiretinal membrane treated by vitrectomy
Key exclusion criteria
glaucoma, pathologic myopia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Baba |
Organization
Chiba University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-8-1 Inohana, CHuo-ku, Chiba, Japan
TEL
043-222-7171
babatakayuki@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Baba |
Organization
Chiba University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-8-1 Inohana, CHuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
babatakayuki@nifty.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The association for retinal detachment
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
2066
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
| 2015 | Year | 06 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
waiting for data
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2015 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020940
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
