UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027810 |
|---|---|
| Receipt number | R000031701 |
| Scientific Title | Comparison of hemi-temporal ILM peeling and total ILM peeling in patients with macular hole |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/06/19 11:10:25 |
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Basic information
Public title
Comparison of hemi-temporal ILM peeling and total ILM peeling in patients with macular hole
Acronym
Hemi-temporal ILM peeling in MH
Scientific Title
Comparison of hemi-temporal ILM peeling and total ILM peeling in patients with macular hole
Scientific Title:Acronym
Hemi-temporal ILM peeling in MH
Region
| Japan |
Condition
Condition
macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the hemi-temporal ILM peeling for treatment of macular hole
Basic objectives2
Others
Basic objectives -Others
comparison of displacement of retina
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
comparison of macular hole closure rate
Key secondary outcomes
displacement of retina
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions were performed Hemi-temporal ILM peeling.
Interventions/Control_2
Control were performed 360-degrees ILM peeling.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Idiopathic macular hole
Key exclusion criteria
macular hole associated retinal detachment
myopic macular hole
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AKIRA SHIONO |
Organization
St marianna university of medicine
Division name
Department of ophthalmology
Zip code
Address
miyamae-ku sugao 2-16-1 kawasaki city kanagawa prefecture
TEL
044-977-8111
shiono1227@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ahiono |
Organization
St marianna university of medicine
Division name
Department of ophthalmology
Zip code
Address
miyamae-ku sugao 2-16-1 kawasaki city kanagawa prefecture
TEL
044-977-8111
Homepage URL
shiono1227@gmail.com
Sponsor or person
Institute
St marianna university of medicine
Department of ophthalmology
Institute
Department
Personal name
Funding Source
Organization
none
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 | 07 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 19 | 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 | 06 | Month | 19 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031701
