UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035091 |
|---|---|
| Receipt number | R000040004 |
| Scientific Title | Temporal Inverted Internal Limiting Membrane Flap Technique for refractory Macular Holes |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2018/11/30 20:13:07 |
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Basic information
Public title
Temporal Inverted Internal Limiting Membrane Flap Technique for refractory Macular Holes
Acronym
Temporal Inverted ILM Flap Technique
Scientific Title
Temporal Inverted Internal Limiting Membrane Flap Technique for refractory Macular Holes
Scientific Title:Acronym
Temporal Inverted ILM Flap Technique
Region
| Japan |
Condition
Condition
Macular hole
Classification by specialty
| Nephrology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of temporal inverted internal limiting membrane flap technique for macular holes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The final rate of macular hole closure
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
refractory MHs, including large MHs (minimal diameter, over 400 micro meter), chronic MHs (symptomatic duration, over 24 months), MHs in high myopia (axial length, over 26 mm), and MHs in patients who could not maintain postoperative prone positioning after vitrectomy
Key exclusion criteria
Patients with a history of retinal surgery, retinal detachment, diabetic retinopathy, retinal vascular occlusion, uveitis, and trauma were excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Takai |
Organization
Shimane university
Division name
Ophthalmology
Zip code
Address
Enya 89-1, Izumo, Shimane
TEL
0853-20-2284
takai611@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Takai |
Organization
Shimane university
Division name
Ophthalmology
Zip code
Address
Enya89-1, Izumo, Shimane
TEL
0853-20-2284
Homepage URL
takai611@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
Funding Source
Organization
Shimane university
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
| 2018 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
The MHs closed successfully in all (100%) eyes postoperatively in 20 refractory macular hole patients.
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040004
