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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006843
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Opthalmology Kansai Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008093

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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