UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015342 |
|---|---|
| Receipt number | R000017842 |
| Scientific Title | Can modified setting of retinal photocoagulation during vitrectomy reduce complications? |
| Date of disclosure of the study information | 2014/10/05 |
| Last modified on | 2016/03/27 21:12:55 |
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Basic information
Public title
Can modified setting of retinal photocoagulation during vitrectomy reduce complications?
Acronym
Modified setting of retinal photocoagulation during vitrectomy for complication reduce.
Scientific Title
Can modified setting of retinal photocoagulation during vitrectomy reduce complications?
Scientific Title:Acronym
Modified setting of retinal photocoagulation during vitrectomy for complication reduce.
Region
| Japan |
Condition
Condition
Diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of modified retinal photocoagulation during vitrectomy can reduce complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Complications after operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High power laser
Interventions/Control_2
Control laser
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
Diabetes patients those who receive vitrectomy for diabetic retinopathy.
Key exclusion criteria
Patients who have severe general complications, pregnancy, intellectual disability and severe allergy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5027
sugmochi@clin.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5027
Homepage URL
sugmochi@aqua.ocn.ne.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie University Hospital
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
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
| 2014 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017842
| 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 |
