UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006843 |
|---|---|
| Receipt number | R000008093 |
| Scientific Title | A clinical case controled for the intraocular tamponade material in the vitretomy for idiopathic macular hole. |
| Date of disclosure of the study information | 2011/12/15 |
| Last modified on | 2011/12/05 22:14:04 |
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Basic information
Public title
A clinical case controled for the intraocular tamponade material in the vitretomy for idiopathic macular hole.
Acronym
Macular hole tamponade study
Scientific Title
A clinical case controled for the intraocular tamponade material in the vitretomy for idiopathic macular hole.
Scientific Title:Acronym
Macular hole tamponade study
Region
| Japan |
Condition
Condition
Idiopathic macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sulfer hexafluoride(SF6) is commonly used for the treatment of the idiopathic macular hole.In order to make face down position of post operative 3-5days.After vitrectomy using other kinds of tamponade materials. We hypothesize to use room air instead of SF6 would be able to make face down term shorter than that of SF6.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
We try to compare the improvement of macular hole closer rate and BCVA after vitrectomy at the point of 1.3. 6.12 month post operatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We replace vitreous with air at the end of surgery.
The air tamponade will disappear applox. 7 days.
Interventions/Control_2
We replace vitreous with SF6 at the end of surgery.
The SF6 tamponade will disappear applox. 14 days.
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 macular hole patients who consulted this hospital and meet following criterion.
.A clinical record at the time of study entry contains no deficiency for essential points.
.20 years old or older.
.The affected eye can be evaluated with
Gass' elassification of macular hole using Optical Coherence Tomography(OCT).
.The affected eye should have no other clinically significant abnormality which may cause loss of vision.
Key exclusion criteria
.When the patient does not hope for entry.
.In the case when there is a unpredicted
worsening of the disease or advance event which the patient should exit this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimitsu Ishiguro |
Organization
Kansai Medical University
Division name
Opthalmology Hirakata Hospital
Zip code
Address
2-3-1 shinmachi hirakata osaka
TEL
0728040101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshimitsu Ishiguro |
Organization
Kansai Medical University
Division name
Opthalmology Hirakata Hospital
Zip code
Address
TEL
0728040101
Homepage URL
Sponsor or person
Institute
Opthalmology Kansai Medical University
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
| 2011 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 12 | Month | 05 | Day |
Last modified on
| 2011 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008093
