UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015363 |
|---|---|
| Receipt number | R000017879 |
| Scientific Title | ILM Blue assisted membrane peeling in vitrectomy |
| Date of disclosure of the study information | 2014/11/15 |
| Last modified on | 2016/04/07 16:57:21 |
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Basic information
Public title
ILM Blue assisted membrane peeling in vitrectomy
Acronym
ILM Blue assisted membrane peeling in vitrectomy
Scientific Title
ILM Blue assisted membrane peeling in vitrectomy
Scientific Title:Acronym
ILM Blue assisted membrane peeling in vitrectomy
Region
| Japan |
Condition
Condition
macular hole, epiretinal membrane, macular edema, retinoschisis, retinal detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the safety and the efficacy of ILM Blue assisted membrane peeling
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the frequency and the content of adverse effects
Key secondary outcomes
visual acuity change in 1, 3, and 12 months after surgery
visual field change in 3 and 12 months after surgery
the quality of ILM staining
the rate of complete ILM peeling
the rate of macular hole
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ILM staining with ILM Blue
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 diagnosis of macular hole, macular edema, epiretinal membrane, retinoschisis, or retinal detachment by slit lamp microscopy, fundusscopy, and optical coherence tomography.
And required surgical treatment.
Key exclusion criteria
1.2 or better of visual acuity
the patients with glaucoma
younger than 20 years old, nursing women, pregnancy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suzuma Kiyoshi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
54ShogoinKawaharacho, Sakyo, Kyoto, Japan
TEL
075-751-3248
suzuma@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Higashiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
54ShogoinKawaharacho, Sakyo, Kyoto, Japan
TEL
075-751-3250
Homepage URL
ahigashi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of Ophthalmology and Visual Science
Institute
Department
Personal name
Funding Source
Organization
donation money for research
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 | 11 | Month | 15 | 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
| 2014 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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 | 07 | Day |
Last modified on
| 2016 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017879
