UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of a novel laser visual aid's potential to improve visual ability of ophthalmic patients
Title of the study (Brief title)	Evaluation of a novel laser visual aid
Region	Japan

Condition
Condition	Ophthalmic diseases causing visual impairment in general, including refractive error and ocular media opacity
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A novel retianl imaging laser eyewear (LEW) scans a narrow laser beam on the retina to enable wearers to see focus-free, full-color images. This LEW is expected to be useful as a visual aid for people with vision impairment. The purpose of this exploratory study is to assess the possibility of the LEW to improve visual ability of ophthalmology patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity measured with Landolt's chart before, during, and after the use of LEW
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	Single arm Intervention: the use of LEW term: several minutes Control: self control
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	Patients with visual impairment due to refractive error or media opacity, with no retrobulbar disorders. Provision of signed and dated informed consent prior to any study procedures.
Key exclusion criteria	Unwillingness to provide consent to any study procedures Inability of self-judgement
Target sample size	200

Research contact person
Name of lead principal investigator	Satoshi Kato
Organization	The University of Tokyo Hospital
Division name	The 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 Hospital
Division name	The Department of Ophthalmology
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	takahiro.minami@gmail.com

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

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	2018 Year 01 Month 08 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 15 Day
Anticipated trial start date	2018 Year 01 Month 09 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 01 Month 08 Day
Last modified on	2018 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035079