UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029720 |
|---|---|
| Receipt number | R000033962 |
| Scientific Title | Feasibility assessment of intraoperative endoillumination with controlled spectral distribution. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2017/10/26 11:11:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Acronym
Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Scientific Title
Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Scientific Title:Acronym
Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Region
| Japan |
Condition
Condition
vitreoretinal diseases (epiretinal membrane, macular hole, diabetic retinopathy, retinal detachment, retinal hemorrhage)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess visibility of retinal lesions using endoillumination with controlled spectral distribution during surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of intraoperative complication
Key secondary outcomes
visibility of retinal lesion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
use endoillumination with control spectral distribution light source for about 5 minuits per surgery.
Interventions/Control_2
use endoillumination with usual light source
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
one who will receive vitreoretinal surgery
Key exclusion criteria
one without consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sujin Hoshi |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Ophthalmology
Zip code
Address
1-1-1 Tennoudai, Tsukuba-city, Ibaraki, Japan
TEL
029-853-3148
hoshisujin@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sujin Hoshi |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Ophthalmology
Zip code
Address
1-1-1 Tennoudai, Tsukuba-city, Ibaraki, Japan
TEL
029-853-3148
Homepage URL
hoshisujin@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
| 2017 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | 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
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2017 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033962
