UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048472 |
|---|---|
| Receipt number | R000055243 |
| Scientific Title | Registration of vitrectomy for epiretinal membrane by Japanese Retina and Vitreous Society |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2024/01/26 11:23:52 |
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Basic information
Public title
Registration of vitrectomy for epiretinal membrane by Japanese Retina and Vitreous Society
Acronym
Registration of vitrectomy for epiretinal membrane by Japanese Retina and Vitreous Society
Scientific Title
Registration of vitrectomy for epiretinal membrane by Japanese Retina and Vitreous Society
Scientific Title:Acronym
Registration of vitrectomy for epiretinal membrane by Japanese Retina and Vitreous Society
Region
| Japan |
Condition
Condition
Epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the situation of vitrectomy for epiretinal membrane in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To summarize the data of vitrectomy for epiretinal membrane
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All patients who receive vitrectomy for epiretinal membrane in the applicable institution
Key exclusion criteria
Patient who reject the participation in the research
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akitaka |
| Middle name | |
| Last name | Tsujikawa |
Organization
Kyoto university
Division name
Ophthalomology
Zip code
6068507
Address
54, shogoinkawaharacho, Sakyoku, Kyoto
TEL
075-751-3250
tujikawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ishihara |
Organization
Kyoto university
Division name
Ophthalomology
Zip code
6068507
Address
54, shogoinkawaharacho, Sakyoku, Kyoto
TEL
075-751-3250
Homepage URL
ikenx2@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japanese Retina and Vitreous Society
Institute
Department
Personal name
Funding Source
Organization
Japanese Retina and Vitreous Society
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2022 | Year | 07 | Month | 26 | 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
| 2022 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are going to collect data of the patients including age, sex, past history, visual function, symptoms, clinical findings, OCT data, shape of eye ball, surgical technique, complications and visual outcome.
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055243
