UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031553 |
|---|---|
| Receipt number | R000036019 |
| Scientific Title | Accommodation auxiliary effect by low addition power contact lens |
| Date of disclosure of the study information | 2018/03/02 |
| Last modified on | 2019/09/02 09:06:18 |
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Basic information
Public title
Accommodation auxiliary effect by low addition power contact lens
Acronym
Accommodation auxiliary effect by low addition power contact lens
Scientific Title
Accommodation auxiliary effect by low addition power contact lens
Scientific Title:Acronym
Accommodation auxiliary effect by low addition power contact lens
Region
| Japan |
Condition
Condition
Accommodative dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the accommodation auxiliar effect by low addition power contact lens. Contribution to the improvement of accommodation dysfunction and corresponding quality of vision will be expected.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitude of accommodation
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Daily life with contact lens specifically prescribed for this study
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Capable of wearing soft contact lens longer than 8 hours more than 5 times a week; Working with visual display terminals such as smartphone or computer more than 3 hours day; Ones who provided informed consent after receiving an explanation of the nature and possible consequences of the study
Key exclusion criteria
Hard contact lens wearers; Having clinically significant anterior segment abnormalities; Orthokeratology lens wearers; Previous history of refractive surgery or cataract surgery; Having ocular or systemic disease; Pregnant or lactating females; Taking any medicine that may influence the accommodation; Ones considered as inappropriate subjects for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shizuka Koh |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Innovative Visual Science
Zip code
Address
2-2 Yamadaoka, Suita Osaka, 565-0871, Japan
TEL
(+81)6-6879-3456
skoh@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shizuka Koh |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Innovative Visual Science
Zip code
Address
2-2 Yamadaoka, Suita Osaka, 565-0871, Japan
TEL
(+81)6-6879-3456
Homepage URL
skoh@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Seed
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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 | 03 | Month | 02 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 10 | 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
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036019
