UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014165 |
|---|---|
| Receipt number | R000016499 |
| Scientific Title | To make database of cases of vitreoretinal diseases treated by vitreoretinal surgeries at Department of Ophthalmology Yamagata University,Faculty of Medicine. |
| Date of disclosure of the study information | 2014/06/05 |
| Last modified on | 2021/06/09 19:27:51 |
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Basic information
Public title
To make database of cases of vitreoretinal diseases treated by vitreoretinal surgeries at Department of Ophthalmology Yamagata University,Faculty of Medicine.
Acronym
To make database of cases of vitreoretinal diseases treated by vitreoretinal surgeries at Department of Ophthalmology Yamagata University,Faculty of Medicine.
Scientific Title
To make database of cases of vitreoretinal diseases treated by vitreoretinal surgeries at Department of Ophthalmology Yamagata University,Faculty of Medicine.
Scientific Title:Acronym
To make database of cases of vitreoretinal diseases treated by vitreoretinal surgeries at Department of Ophthalmology Yamagata University,Faculty of Medicine.
Region
| Japan |
Condition
Condition
vitreoretinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make database of cases of vitreoretinal disease treated by vitreoretinal surgeries, to identify factors correlated with visual outcomes after vitreoretinal surgeries.
Basic objectives2
Others
Basic objectives -Others
To identify factors correlated with visual outcomes after vitreoretinal surgeries.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors correlated with outcomes after vitreoretinal surgeries
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who agreed with participating in this study.
Patients treated by vitreous surgery for vitreoretinal diseases.
Key exclusion criteria
Patients who disagreed with participating in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Yamashita |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
990-2332
Address
2-2-2 Iidanishi, Yamagata
TEL
023-628-5374
hyama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Yamashita |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
990-2331
Address
2-2-2 Iidanishi, Yamagata
TEL
023-628-5374
Homepage URL
hyama-tky@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Sciences Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology and Visual Sciences Yamagata University Faculty 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
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2, Iida-nishi, Yamagata
Tel
023-628-5047
ikekenkyu@jm.kj.yamagata-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
山形大学医学部附属病院(山形県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1371/journal.pone.0244281
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 14 | Day |
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
| 2014 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe outcomes after vitreous surgery for vitreoretinal diseases.
We evaluate correlation between systemic and local factors and outcomes after vitreoretinal surgeries.
Management information
Registered date
| 2014 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016499
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
