UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026998
Receipt No. R000030954
Scientific Title Evaluation of choroidal structure before and after strabismus surgery
Date of disclosure of the study information 2017/04/15
Last modified on 2017/04/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of choroidal structure before and after strabismus surgery
Acronym Evaluation of choroidal structure before and after strabismus surgery
Scientific Title Evaluation of choroidal structure before and after strabismus surgery
Scientific Title:Acronym Evaluation of choroidal structure before and after strabismus surgery
Region
Japan

Condition
Condition strabismus
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence on the choroidal structure of strabismus surgery
Basic objectives2 Others
Basic objectives -Others morphological change
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of choroidal structure
Key secondary outcomes refractive error
angle of deviation

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Examination by optical coherence tomography before and one day and two weeks after strabismus surgery.
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
3 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with strabismus surgery
Key exclusion criteria The lack of cooperation with examination
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Gomi Fumi
Organization Hyogo College Of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6111
Email fgomi@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Iwami Hisashi
Organization Hyogo College Of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6111
Homepage URL
Email hi-iwami@hyo-med.ac.jp

Sponsor
Institute Hyogo College Of Medicine
Institute
Department

Funding Source
Organization Hyogo College Of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 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
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 14 Day
Last modified on
2017 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030954

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.