UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047937 |
|---|---|
| Receipt number | R000054648 |
| Scientific Title | visual function and satisfaction with photochromic contact lenses |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2023/06/06 12:10:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
visual function and satisfaction with photochromic contact lenses
Acronym
visual function of photochromic contact lenses
Scientific Title
visual function and satisfaction with photochromic contact lenses
Scientific Title:Acronym
visual function of photochromic contact lenses
Region
| Japan |
Condition
Condition
Normal subject
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare visual function and subject satisfaction during wearing high performance contact lenses, such as photochromic contact lens with those during wearing conventional contact lens.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visualu acuity, functional visual acuity, kinetic visual acuity, contrast sensitivity, corneal higher-order aberrations, satisfaction.
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
| Medicine |
Interventions/Control_1
visual acuity, functional visual acuity, kinetic visual acuity, contrast sensitivity function under photopic conditions, and corneal higher-order aberration in photochromic contact lens with those during wearing conventional contact lens.
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
Cases having no ophthalmologic diseases except for refractive error
cases have corrected visual acuity of 1.0 or better
Use soft contact lenses on a daily
Key exclusion criteria
Cases having ophthalmologic diseases
astigamatism >1.00D
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
2520373
Address
1-15-1, kitasato, minamiku, sagamihara, kanagawa
TEL
0427789679
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shuya |
| Middle name | |
| Last name | Suzuki |
Organization
Kitasato University
Division name
graduate school of medical science
Zip code
2520373
Address
1-15-1, kitasato, minamiku, sagamihara, kanagawa
TEL
0427788602
Homepage URL
suzuki.shuya@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
Kitasato University
Address
1-15-1, kitasato, minamiku, sagamihara, kanagawa
Tel
042-778-9173
a-kyoumu(AT)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
| 2022 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s40123-022-00552-5
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s40123-022-00552-5
Number of participants that the trial has enrolled
41
Results
Kinetic visual acuity (30 and 60 km/h), functional visual acuity, and patient satisfaction score were significantly better in the photochromic CL group than that in the non-photochromic CL group (Wilcoxson signed-rank test, p = 0.008, p = 0.034, p = 0.030, and p < 0.001).
Results date posted
| 2023 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All subjects were required to have best-corrected visual acuity of 20/20 or better in each eye with the cylindrical correction being limited to 1 diopter (D) or less. Eyes with any history of ocular surgery, ocular trauma, and other concomitant eye diseases were excluded from the study.
Participant flow
We randomly measured only one eye for each subject for data analysis. We quantitatively assessed visual acuity at 5 m, using a decimal acuity chart of Landolt rings shown under photopic conditions (600 lx) in an indoor environment, kinetic visual acuity (KVA), functional visual acuity (FVA), ocular higher-order aberrations (HOAs), contrast sensitivity (CS) function, subject satisfaction for the overall vision, and adverse events and complications, during photochromic and non-photochromic CL wear in daily use.
Adverse events
none
Outcome measures
visual acuity,Kinetic Visual Acuity,Functional Visual Acuity,Ocular Higher-Order Aberrations,Contrast Sensitivity Function,Satisfaction Score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054648
