UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047938 |
|---|---|
| Receipt number | R000054650 |
| Scientific Title | Effectiveness of Toric Contact Lenses in Correcting Astigmatism and Satisfaction with Toric Contact Lenses |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2023/06/06 11:39:42 |
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Basic information
Public title
Effectiveness of Toric Contact Lenses in Correcting Astigmatism and Satisfaction with Toric Contact Lenses
Acronym
visual function of toric contact lenses
Scientific Title
Effectiveness of Toric Contact Lenses in Correcting Astigmatism and Satisfaction with Toric Contact Lenses
Scientific Title:Acronym
visual function of toric contact lenses
Region
| Japan |
Condition
Condition
Normal subject
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the visual function of patients wearing toric SCLs and those wearing soft contact lenses with spherical lens action only (spherical SCLs), and to examine the astigmatism correction effect of toric SCLs.
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 toric 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
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@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
http://www.clgakkai.jp/
Publication of results
Published
Result
URL related to results and publications
http://www.clgakkai.jp/
Number of participants that the trial has enrolled
41
Results
There were significant differences between uncorrected and fully corrected subjects in visual acuity, kinetic visual acuity, functional visual acuity (mean visual acuity and visual acuity maintenance), and contrast sensitivity, and also between undercorrected and fully corrected subjects in visual acuity in the distance, 30 km/h in kinetic visual acuity, and high frequency contrast sensitivity (18 cpd).
Results date posted
| 2023 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were college students aged 20 years or older with good judgment who were regular SCL users and had no ocular diseases other than refractive error. The total number of subjects was 41 students with 41 eyes (mean age 21.7years, 16 males with 16 eyes and 25 females with 25 eyes).
Participant flow
First, the left and right eyes were randomized and then the subjects were fitted with cylindrical lenses in an optometric frame aligned with the subject's astigmatic axis, intentionally creating astigmatism so that the total astigmatism of all subjects was 1.75 D. The subjects were fitted with toric SCLs (One Day Acuvue Moist for Astigmatism, J&J Vision) with astigmatism levels of 0.75 D and 1.75 D to fully correct astigmatism (residual cylinder level of 0 D) and low correction (residual cylinder level of 1.00 D), respectively. The subjects wore spherical SCL (One Day Acuvue Moist, J&J Vision) so that their astigmatism was uncorrected (residual cylinder power 1.75 D), and the test items were compared. All spherical power values were equivalent spherical values, and the minimum circle of confusion was placed on the retinal surface. Only one eye was fitted with an SCL, and the analysis was performed on one eye per case.
Adverse events
none
Outcome measures
visual acuity, kinetic visual acuity, functional visual acuity, contrast sensitivity, higher-order aberrations, and satisfaction.
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=R000054650
