UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022181 |
|---|---|
| Receipt number | R000025554 |
| Scientific Title | Study concerning improvement made on quality of vision when wearing microdot lenses |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2023/05/08 09:21:09 |
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Basic information
Public title
Study concerning improvement made on quality of vision when wearing microdot lenses
Acronym
Study concerning improvement made on quality of vision when wearing microdot lenses
Scientific Title
Study concerning improvement made on quality of vision when wearing microdot lenses
Scientific Title:Acronym
Study concerning improvement made on quality of vision when wearing microdot lenses
Region
| Japan |
Condition
Condition
Eyestrain, Decrease in visual function
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test hypotheses regarding how much microdot lenses employ the difference between refractive index and transmittance to reduce the amount of light that directly enters the eye as well as use the pinhole effect. This is used a means to improve visual function, vision quality, and eye fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Immediately after wearing
Accommodative measurement
Key secondary outcomes
Immediately after wearing
Vision Test
Contrast sensitivity
New Functional Visual Acuity Measurement System
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
1. Group using microdot lenses A
2. Group using microdot lenses B
3. Group using control lenses
Interventions/Control_2
1. Group using microdot lenses B
2. Group using control lenses
3. Group using microdot lenses B
Interventions/Control_3
1. Group using control lenses
2. Group using microdot lenses A
3. Group using microdot lenses B
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Corrected visual acuity of more than 1.0
Key exclusion criteria
Those who cannot come to the hospital during on the survey date
Those who have received some form of eye treatment in the past
Those who have had eye surgery
Those currently undergoing eye treatment
Those who have gotten LASIK
Those with a corrected visual acuity of less than 1.0
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Toda |
Organization
Minamiaoyama Eye Clinic
Division name
Dept. of Ophthalmology
Zip code
107061
Address
3-3-11 Rune Aoyama Bldg. 4F, Kitaaoyama, Minato-ku, Tokyo 107-0061 Japan
TEL
03-5772-1451
toda@minamiaoyama.or.jp
Public contact
Name of contact person
| 1st name | Kimiko |
| Middle name | |
| Last name | Nakabayashi |
Organization
Medi Produce Inc.
Division name
Medi Produce Inc.
Zip code
1070062
Address
2-26-35, 8F, Minamiaoyama, Minato-ku, Tokyo 107-0062 Japan
TEL
03-5775-6070
Homepage URL
nakabayashi@mediproduce.com
Sponsor or person
Institute
Miamiaoyama Eye Clinic, Ikuko Toda
Institute
Department
Personal name
Funding Source
Organization
JIN CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Minamiaoyama Eye Clinic
Address
3-3-11 kitaaoyama
Tel
0357721440
Irb@minamiaoyama.orjp
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
南青山アイクリニック（Minamiaoyama Eye Clinic）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
After surveying the effects of using microdot lenses on the focus adjustment response, it was found that microdot lenses reduced the time to interpret text by 4%.
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 06 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 06 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 06 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
A Study on visual effect of micro dot lens
Optical Characteristics of Micro Dot Lens and Its Effects on Visual Function
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025554
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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