UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042575 |
|---|---|
| Receipt number | R000048568 |
| Scientific Title | Evaluation of visual function when wearing blue and yellow light cut lenses |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/12/01 20:08:08 |
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Basic information
Public title
Evaluation of visual function when wearing blue and yellow light cut lenses
Acronym
Evaluation of visual function when wearing blue and yellow light cut lenses
Scientific Title
Evaluation of visual function when wearing blue and yellow light cut lenses
Scientific Title:Acronym
Evaluation of visual function when wearing blue and yellow light cut lenses
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Colored intraocular lenses that block short-wavelength light are now used in cataract surgery. This lens was developed to improve color perception, photophobia, and retinal light damage caused by short-wavelength light, which were problems with conventionally used unpigmented intraocular lenses. However, the blue-on-yellow field of view (SWAP), an effective visual field test for detecting early-stage glaucoma, uses short-wavelength light for measurement, and its impact on the test was a concern. In previous reports, there was no significant difference between tinted and untainted lenses. On the other hand, there were reports of a decrease in values, and further study is required. Since the spectral transmittance of colored intraocular lenses differs from company to company, it is suggested that differences in spectral transmittance may be involved. In the present study, we used short- and medium-wavelength light-blocking lenses (blue and yellow-light-cut lenses) and other lenses with different spectral transmittances to examine the effects of differences in spectral transmittance on SWAP and visual function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, gender, ocular axis length, refraction, non-use of blue and yellow light cut lenses, use of blue and yellow-it cut lenses
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
| Device,equipment |
Interventions/Control_1
Ocular axis length, refractive measurements, no blue and yellow light cut lenses, blue and yellow-it cut lenses
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study subjects must have corrected visual acuity of 1.0 or better without eye diseases (trauma, retinal detachment, severe dry eye, corneal disease) and without color blindness
Key exclusion criteria
1. those with corrected vision 1.0 or less
2. those with astigmatism of -1.00 D or greater
3. those who have poor fixation of 10% or more, false positives and false negatives of 20% or more on the visual field test
4. a person with color blindness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takushi |
| Middle name | |
| Last name | Kawamorita |
Organization
Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
252-0373
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
0427789662
kawa2008@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takushi |
| Middle name | |
| Last name | Kawamorita |
Organization
Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa, Japan 252-0373
TEL
0427789662
Homepage URL
kawa2008@kitasato-u.ac.jp
Sponsor or person
Institute
The Kitasato Institute
Institute
Department
Personal name
Funding Source
Organization
The Kitasato Institute
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
Kitasto University Hospital,
Address
IRB Office
Tel
042-778-9602
a-soumu@kitasato-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
| 2021 | Year | 04 | Month | 01 | 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
60
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
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048568
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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