UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033328 |
|---|---|
| Receipt number | R000037991 |
| Scientific Title | 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 06:52:24 |
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Basic information
Public title
Evaluation on visual acuity achieved with a newly developed laser visual assisting device in ophthalmic patients
Acronym
Scanning laser visual acuity in ophthalmic patients
Scientific Title
Evaluation on visual acuity achieved with a newly developed laser visual assisting device in ophthalmic patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Satoshi Kato |
Organization
The University of Tokyo Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
katou-s@ka2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Minami |
Organization
The University of Tokyo Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
takaminami-tky@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, The University of Tokyo School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037991
