UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019581 |
|---|---|
| Receipt number | R000022636 |
| Scientific Title | Inverted internal limiting membrane flap technique using ophthalmic viscosugical device for refractory macular hole |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2017/11/09 18:18:18 |
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Basic information
Public title
Inverted internal limiting membrane flap technique using ophthalmic viscosugical device for refractory macular hole
Acronym
Inverted internal limiting membrane flap technique using ophthalmic viscosugical device for macular hole
Scientific Title
Inverted internal limiting membrane flap technique using ophthalmic viscosugical device for refractory macular hole
Scientific Title:Acronym
Inverted internal limiting membrane flap technique using ophthalmic viscosugical device for macular hole
Region
| Japan |
Condition
Condition
macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of inverted internal limiting membrane flap technique using ophthalmic viscosurgical device for refractory macular hole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
success rate of macular hole closure at 2 weeks after surgery
Key secondary outcomes
visual acuity at 2weeks,3,6,and 12 months after surgery
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
Ophthalmic viscosurgical device is put to fix inverted internal limiting membrane.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
large macular hole
old macular hole
macular hole with high myopic eye
Key exclusion criteria
vitrectomiezed eye
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Horiguchi |
Organization
Fujita Health University Hospital
Division name
Ophthalmology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL
81-0562-95-5177
masayuki@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Tanaka |
Organization
Fujita Health University Hospital
Division name
Ophthalmology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL
81-0562-95-5177
Homepage URL
hide73t@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
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
| 2016 | Year | 01 | Month | 04 | 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
| 2015 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | 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
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2017 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022636
