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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033328
Receipt No. R000037991
Official scientific title of the study Evaluation on visual acuity achieved with a newly developed laser visual assisting device in ophthalmic patients
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/10

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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