UMIN-CTR Clinical Trial

Basic information
Public title	Eye movement for intermittent exotropia
Acronym	Eye movement of intermittent exotropia
Scientific Title	Eye movement for intermittent exotropia
Scientific Title:Acronym	Eye movement of intermittent exotropia
Region	Japan

Condition
Condition	intermittent exotropia
Classification by specialty	Ophthalmology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate for eye movement of intermittent exotropia by video oculography during the reading of text.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Saccadic disconjugacy in the intermittent exotropia group and taht in the control group during reading
Key secondary outcomes

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	Other
Interventions/Control_1	A novel sentences were displayed on a liquid crystal monitor placed horizontally. The subjects read the sentences less than 10 pages. The subject's eye movement is measured using a high-speed video oculography.
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	8 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	No eye disease without refractive error in the control group. The patient with intermittent exotropia. Volunteers who were informed of this study and consented to participate.
Key exclusion criteria	Volunteers who have eye disease without refractive error and intermittent exotropia
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Fujikado
Organization	Osaka university graduate school of medicine
Division name	Department of applied visual science
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3941
Email	fujikado@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Masakazu Middle name Last name Hirota
Organization	Osaka university graduate school of medicine
Division name	Department of applied visual science
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3943
Homepage URL
Email	hirota@sensory.med.osaka-u.ac.jp

Sponsor
Institute	Department of applied visual science, Osaka university graduate school of medicine
Institute
Department

Funding Source
Organization	Department of applied visual science, Osaka university graduate school of medicine
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	Osaka university
Address	2-2 yamadaoka, suita osaka
Tel	06-6210-8295
Email	565-0871

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 02 Month 29 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	40
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	Completed
Date of protocol fixation	2016 Year 02 Month 20 Day
Date of IRB	2014 Year 06 Month 13 Day
Anticipated trial start date	2016 Year 02 Month 29 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 29 Day
Last modified on	2021 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024505