UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007564 |
|---|---|
| Receipt number | R000008936 |
| Scientific Title | Inverted internal limiting membrane flap technique for macular hole retinal detachment. |
| Date of disclosure of the study information | 2012/04/02 |
| Last modified on | 2017/04/04 16:24:14 |
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Basic information
Public title
Inverted internal limiting membrane flap technique for macular hole retinal detachment.
Acronym
Inverted internal limiting membrane flap technique for macular hole retinal detachment.
Scientific Title
Inverted internal limiting membrane flap technique for macular hole retinal detachment.
Scientific Title:Acronym
Inverted internal limiting membrane flap technique for macular hole retinal detachment.
Region
| Japan |
Condition
Condition
Macular hole retinal detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess efficacy and safety of inverted internal limiting membrane flap technique in patients with macular hole retinal detachment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Initial reattachment rate
Key secondary outcomes
Best corrected visual acuity, closeure rate of macular hole
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Vitrectomy with inverted internal limiting membrane and 20% SF6 gas tamponade. Patients must keep prone position 1 week after surgery and avoid supine position until intravitreous gas vanished.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 20< years of age <80
2) Macular hole retinal detachment with axial length >26 mm
3) No prior vitrectomy
4) Be able to keep prone position and fill out a questionnaire
5) Written imformed consent
Key exclusion criteria
1) Prolifelative vitreoretinopathy
2) Judged as inappropriate by doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Yamane |
Organization
Yokohama City University Medical Center
Division name
Ophthalmology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
shinyama@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Yamane |
Organization
Yokohama City University Medical Center
Division name
Ophthalmology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
shinyama@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
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 | 23 | Day |
Last modified on
| 2017 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008936
