UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of the neural compensation to the contrast sensitivity
Title of the study (Brief title)	neural compensation and contrast sensitivity
Region	Japan

Condition
Condition	normal subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of the neural compensation to the contrast sesitivity
Basic objectives2	Others
Basic objectives -Others	control of myopia progression
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	contrast sensitivity refractive error
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	cycloplegia
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	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	good accommodation
Key exclusion criteria	over 5D myopia over 0.75D astigmatism
Target sample size	6

Research contact person
Name of lead principal investigator	Kinoshita Shigeru
Organization	Kyoto Prefectural University of Medicine
Division name	ophthalmology
Address	465 Kjiicho, Kyoto City
TEL	075-251-5578
Email	shigeruk@koto.kpu-m.ac.jp

Public contact
Name of contact person	Osamu Hieda
Organization	Kyoto Prefectural University of Medicine
Division name	IRB
Address	Kaji-cho 465, Kamigyo-ku, Kyoto City
TEL	075-251-5578
Homepage URL
Email	ohieda@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
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	2012 Year 10 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 10 Month 01 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	Published
URL releasing results
Results	A pupil diameter affects the contrast sensitivity
Other related information

Management information
Registered date	2012 Year 10 Month 01 Day
Last modified on	2016 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010576