UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation on visual acuity achieved with a newly developed laser visual assisting device in ophthalmic patients
Title of the study (Brief title)	Scanning laser visual acuity in ophthalmic patients
Region	Japan

Condition
Condition	Visually impaired eyes with anterior segment disorders
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate how SLD can provide visual acuity as a visual aid method for people with corneal visual impairment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Use of a laser scanning displaying device
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Visually impaired eyes due to refractive errors or media opacities
Key exclusion criteria	Eyes with mild cataract or higher, eyes with other disorders including glaucoma or macular diseases, apparently contributing to reduced visual acuity, or aphakic eyes are excluded.
Target sample size	200

Research contact person
Name of lead principal investigator	Satoshi Kato
Organization	The University of Tokyo Graduate School of Medicine
Division name	Department of Ophthalmology
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	katou-s@ka2.so-net.ne.jp

Public contact
Name of contact person	Takahiro Minami
Organization	The University of Tokyo Graduate School of Medicine
Division name	Department of Ophthalmology
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	takaminami-tky@umin.ac.jp

Sponsor
Institute	Department of Ophthalmology, The University of Tokyo School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology, The University of Tokyo School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	QD Laser Inc.
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	2018 Year 07 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 28 Day
Anticipated trial start date	2016 Year 11 Month 28 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	2018 Year 07 Month 08 Day
Last modified on	2018 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037991