UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of factors affecting strabismus surgery
Acronym	Factors affecting strabismus surgery
Scientific Title	Investigation of factors affecting strabismus surgery
Scientific Title:Acronym	Factors affecting strabismus surgery
Region	Japan

Condition
Condition	Eye disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify factors affecting strabismus surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between the results of strabismus surgery and methods, and between the results of strabismus surgery and patient factors.
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	Subjects undergo ophthalmic examinations and strabismus surgery.
Key exclusion criteria	Subjects with previous intraocular surgery.
Target sample size	264

Research contact person
Name of lead principal investigator	1st name Yugo Middle name Last name Yugo
Organization	Kimura eye and internal medicine hospital
Division name	Department of ophthalmology
Zip code	737-0029
Address	3-15 Takaramachi, Kure, Hiroshima
TEL	0823-22-5544
Email	ky.kimuraeye@gmail.com

Public contact
Name of contact person	1st name Yoshitaka Middle name Last name Nakao
Organization	Kimura eye and internal medicine hospital
Division name	Department of ophthalmology
Zip code	737-0029
Address	3-15 Takaramachi, Kure, Hiroshima
TEL	0823-22-5544
Homepage URL
Email	Yoshitaka.nakao@kimura-eye.or.jp

Sponsor
Institute	Kimura eye and internal medicine hospital
Institute
Department

Funding Source
Organization	Kimura eye and internal medicine hospital
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	Kimura eye and internal medicine hospital
Address	3-15 Takaramachi, Kure, Hiroshima
Tel	0823-22-5544
Email	kimura.eye.int@green.ocn.ne.jp

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 08 Month 13 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	2018 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 08 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is prospectively investigate the relationship between the results of strabismus surgery and methods, and also between the results of strabismus surgery and patient factors. The Department of Ophthalmology of Kimura eye and internal medicine hospital recruited participants from August 2018. All patients underwent a full ophthalmic examination that included strabismus measurements.

Management information
Registered date	2018 Year 08 Month 13 Day
Last modified on	2022 Year 01 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038482