UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007517 |
|---|---|
| Receipt number | R000008767 |
| Scientific Title | The study of improvement of macular hole surgery |
| Date of disclosure of the study information | 2012/03/21 |
| Last modified on | 2012/03/16 12:37:49 |
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Basic information
Public title
The study of improvement of macular hole surgery
Acronym
Improvement of MH surgery
Scientific Title
The study of improvement of macular hole surgery
Scientific Title:Acronym
Improvement of MH surgery
Region
| Japan |
Condition
Condition
macular hole
Classification by specialty
| Ophthalmology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the succuess rate of macular hole closure by post-operational posturing period based upon OCT imaging
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
success rate of macular hole closure
Key secondary outcomes
visual acuity, OCT finding
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Period of post-operative posturing deteremined by OCT analysis
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
idiopathic macular hole case with diameter of macular hole less than 500 micrometer measured with OCT
Key exclusion criteria
highly myopic eye (-7.0 diopter or less)
those with an apparent retinal or choroidal diseases including diabetic retinoparhy, age-related macular degeneration, retinal vein occlusion and others
those with a history of retinal surgery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
81-90-275-5402
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifumi Yamashita |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
81-90-275-5402
Homepage URL
http://www.kufm.kagoshima-u.ac.jp/~op/gairai/annai.html
yyamatos@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Ophthalmology, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
A grant from the Ministry of Health, Labor and Welfare, and by a Aid for Scientric Research from the Ministry of Education, Science, and Culture of the Japanese Government
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
鹿児島大学病院、Kagoshima University Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
| 2012 | Year | 03 | Month | 16 | Day |
Last modified on
| 2012 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008767
