UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032821 |
|---|---|
| Receipt number | R000037432 |
| Scientific Title | Effect of inner limiting membrane peeling on retinal thickness and retinal vascular layer for epiretinal membrane and macular hole |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/12/02 09:08:41 |
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Basic information
Public title
Effect of inner limiting membrane peeling on retinal thickness and retinal vascular layer for epiretinal membrane and macular hole
Acronym
Effect of ILP peeling on retinal thickness for ERM and MH
Scientific Title
Effect of inner limiting membrane peeling on retinal thickness and retinal vascular layer for epiretinal membrane and macular hole
Scientific Title:Acronym
Effect of ILP peeling on retinal thickness for ERM and MH
Region
| Japan |
Condition
Condition
epiretinal membrane and macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness and safety of internal limiting membrane peeling in the treatment for epiretinal membrane and macular hole.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
retinal thinning
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who have vitrectomy surgeries ERM and MH and who agree with this study.
Key exclusion criteria
n/a
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
+81-52-7442277
h-kaneko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
+81-52-7442277
Homepage URL
h-kaneko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
n/a
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
+81-52-7442277
hiroki.kaneko2@gmail.com
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
| 2018 | Year | 06 | 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 | 07 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 01 | Day |
Other
Other related information
limited patients recruitment in the approved facility
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2021 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037432
| Research Plan | |
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| 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 |
