UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of monocular occlusion and Prism Adaptation Test in strabismus
Title of the study (Brief title)	The effects of monocular occlusion and Prism Adaptation Test in strabismus
Region	Japan

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

Objectives
Narrative objectives1	To investigate effective methods in order to determine the maximum angle of strabismus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	angle of deviation
Key secondary outcomes	refractive error, binocular visual function

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	1, monocular occlusion 2, monocular occlusion and Prism Adaptation test 3, Prism Adaptation test
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	3 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	exotropia or intermittent exotropia esotropia or intermittent esotropia No eye disease without strabismus and refractive error normal retinal correspondence surgery purpose
Key exclusion criteria	the lack of cooperation with examination
Target sample size	14

Research contact person
Name of lead principal investigator	Noriko Nishikawa
Organization	Asahikawa Medical University
Division name	Department of Ophthalmology
Address	1-1-1 Midorigaoka higashi 2-jo, Asahikawa, Hokkaido
TEL	0166-68-2543
Email	nnori@asahikawa-med.ac.jp

Public contact
Name of contact person	Manami Kawai
Organization	Asahikawa Medical University
Division name	Department of Ophthalmology
Address	1-1-1 Midorigaoka higashi 2-jo, Asahikawa, Hokkaido
TEL	0166-68-2543
Homepage URL
Email	ort-mk@asahikawa-med.ac.jp

Sponsor
Institute	Department of Ophthalmology, Asahikawa Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 06 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 22 Day
Anticipated trial start date	2016 Year 05 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 07 Day
Last modified on	2016 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025958