UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050506 |
|---|---|
| Receipt number | R000057495 |
| Scientific Title | Examination of the effect of electronic lens glasses on visual function |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2024/04/30 10:52:36 |
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Basic information
Public title
Examination of the effect of electronic lens glasses on visual function
Acronym
Examination of the effect of electronic lens glasses on visual function
Scientific Title
Examination of the effect of electronic lens glasses on visual function
Scientific Title:Acronym
Examination of the effect of electronic lens glasses on visual function
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of electronic lens glasses on visual function.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of reducing asthenopia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
electronic lens glasses
Interventions/Control_2
monofocal glasses
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
| 18 | years-old | < |
Age-upper limit
| 39 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Best-corrected visual acuity of decimal visual acuity (1.0) or higher.
Key exclusion criteria
Cylindrical power 1.00 diopter or higher.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Ikeda |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Ophthalmology
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2806
ymocl@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Mawatari |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Ophthalmology
Zip code
889-1692
Address
5200, Kihara, Kiyotake, Miyazaki
TEL
0985-85-2806
Homepage URL
go_mawatari@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.ac.jp
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
| 2023 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
37
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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057495
