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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017143
Receipt No. 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

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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
Last 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
Email babatakayuki@nifty.com

Public contact
1st 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
Email babatakayuki@nifty.com

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019881

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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