UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017143 |
|---|---|
| Receipt number | R000019881 |
| Scientific Title | Pars plana vitrectomy with scleral imbrication for myopic schisis |
| Date of disclosure of the study information | 2015/04/15 |
| Last modified on | 2015/04/15 15:54:17 |
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Basic information
Public title
Pars plana vitrectomy with scleral imbrication for myopic schisis
Acronym
Scleral imbrication for myopic schisis
Scientific Title
Pars plana vitrectomy with scleral imbrication for myopic schisis
Scientific Title:Acronym
Scleral imbrication for myopic schisis
Region
| Japan |
Condition
Condition
myopic schisis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of pars plana vitrectomy combined with scleral imbrication
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
best-corrected visual acuity
Key secondary outcomes
retinal morphology
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
pars plana vitrectomy with scleral imbrication
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
clinicaly diagnosed myopic schisis
axial length greater than 26.5mm
treated by vitrectomy
Key exclusion criteria
past history of intraocular surgery within six months
inflammatory eye disase
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Baba |
Organization
Chiba University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba
TEL
043-222-7171
babatakayuki@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Baba |
Organization
Chiba University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba
TEL
043-222-7171
Homepage URL
babatakayuki@nifty.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Patients association of retinal detachment
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
1820
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 15 | Day |
Last modified on
| 2015 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019881
