UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044277 |
|---|---|
| Receipt number | R000049798 |
| Scientific Title | Optical quality eyes with contact lenses |
| Date of disclosure of the study information | 2021/05/21 |
| Last modified on | 2023/11/22 16:19:21 |
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Basic information
Public title
Optical quality in eyes with contact lenses
Acronym
Contact lens and optical quality
Scientific Title
Optical quality eyes with contact lenses
Scientific Title:Acronym
Contact lens and optical quality
Region
| Japan |
Condition
Condition
Refractive errors
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To objectively evaluate the optical quality in eyes with contact lenses of different design
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Higher-order aberrations
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Contact lens design
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
Experienced SCL wearers between 20 and 39 years of age who had been wearing SCL Wearing SCL at least 8h and 5 days a week
Key exclusion criteria
Having clinically significant anterior segment abnormalities or having ocular or systemic disease that would preclude SCL wear having history of ocular surgery or orthokeratology Being pregnant or lactating Thought to be not eligible by the researchers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shizuka |
| Middle name | |
| Last name | Koh |
Organization
Osaka University Graduate School of Medicine
Division name
Innovative Visual Science
Zip code
565-0871
Address
2-2 Yamadaoka, Suita 565-0871 JAPAN
TEL
06-6879-3456
skoh@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizuka |
| Middle name | |
| Last name | Koh |
Organization
Osaka University Graduate School of Medicine
Division name
Innovative Visual Science
Zip code
565-0871
Address
2-2 Yamadaoka, Suita 565-0871 JAPAN
TEL
06-6879-3456
Homepage URL
skoh@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Innovative Visual Science
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Johnson and Johnson
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
IRB, Osaka university Hospital
Address
2-2 Yamadaoka, Suita 565-0871 JAPAN
Tel
06-6210-8296
rinri-jim@dmi.med.osaka-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 | 05 | Month | 21 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000049798
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_reg_list.cgi
Number of participants that the trial has enrolled
20
Results
ESD-CLs, PB-CL, and no-CL provided better CDVA than spherical CL (p<0.05).
Astigmatism was significantly less with PB-CL and ESD-CLs compared with spherical
CL and no CL (p<0.05). Coma was significantly less with ESD-CLs than PB-CL
(p<0.05); total HOAs did not differ among the four conditions. The subjective ratings for
blurred and double vision were significantly lower with ESD-CLs than with spherical CL
(p<0.05).
Results date posted
| 2023 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 15 | Day |
Baseline Characteristics
Experienced SCLwearers aged 20 to 39 years were eligible to participate in this study if they met the following criteria, wearing SCLs for more than 8 hours per day and more than five days per week, no ocular pathology or systemic disorders, and not receiving any drugs with known effects on visual acuity or accommodation.
Participant flow
After the lens had settled on the eye for at least 10 min after insertion, the assessments were conducted in the following order: (1) CDVA measurement, (2) subjective vision quality assessment, (3) aberrometry, and (4) CL fitting examination and axis misalignment of toric CL using a slit lamp. The same measurement procedure was repeated for all three CLs.
Adverse events
None
Outcome measures
1 CDVA measurement,
2 subjective vision quality assessment
3 wavefront aberrations
4 CL fitting examination and axis misalignment of toric CL
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049798
