UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005828 |
|---|---|
| Receipt number | R000006879 |
| Scientific Title | Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2015/06/23 16:28:15 |
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Basic information
Public title
Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries
Acronym
Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries
Scientific Title
Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries
Scientific Title:Acronym
Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries
Region
| Japan |
Condition
Condition
idiopathic macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is necessary to develop new adjuvant for internalnner limiting membrane peeling of macular hole surgery to avoid retinal damage. We compared the results using newly developed Brilliant Blue G (BBG) with conventional Indocyanine Green (ICG) or Triamcinolone Acetonide (TA).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative visual acuity
initial closure rates
complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
BBG
Interventions/Control_2
ICG
Interventions/Control_3
TA
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 underwent vitreous surgery for idiopathic macular hole at the Yamagata University Hospital and were followed for 3 months or more after surgery.
Key exclusion criteria
MH of stage1
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Mochizuki |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
2-2-2 Iida-nishi yamagata
TEL
0236285374
m.noriko@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Mochizuki |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
2-2-2 Iida-nishi yamagata
TEL
0236285374
Homepage URL
m.noriko@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science,Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25201225
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
| 2007 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | 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
| 2011 | Year | 06 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006879
