UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007951 |
|---|---|
| Receipt number | R000009355 |
| Scientific Title | Inverted internal limiting membrane flap technique for large macular hole |
| Date of disclosure of the study information | 2012/05/15 |
| Last modified on | 2021/05/25 08:40:50 |
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Basic information
Public title
Inverted internal limiting membrane flap technique for large macular hole
Acronym
Inverted internal limiting membrane flap technique for large macular hole
Scientific Title
Inverted internal limiting membrane flap technique for large macular hole
Scientific Title:Acronym
Inverted internal limiting membrane flap technique for large macular hole
Region
| Japan |
Condition
Condition
large macular hole
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 large macular hole.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Closeure rate of macular hole
Key secondary outcomes
Best corrected visual acuity
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 until macular hole closure 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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)20< years of age <85
(2)Be able to keep prone position
(3)Written imformed consent
Key exclusion criteria
highly myopic eye (-6.0 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 | Taiji |
| Middle name | |
| Last name | Sakamoto |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
8900075
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Yamashita |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
8900075
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5402
Homepage URL
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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Hospital
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
Tel
099-275-5402
kufsyomu@kuas.kagoshima-u.ac.jp
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 | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 15 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009355
