UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036881 |
|---|---|
| Receipt number | R000042007 |
| Scientific Title | Comparative study to identify the optical design of soft contact lenses to optimize the reducing effect of myopia progression |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2021/01/14 16:33:48 |
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Basic information
Public title
Study to identify the optical design of soft contact lenses to optimize the reducing effect of myopia progression
Acronym
Optical design of soft contact lenses to optimize the reducing effect of myopia progression
Scientific Title
Comparative study to identify the optical design of soft contact lenses to optimize the reducing effect of myopia progression
Scientific Title:Acronym
Optical design of soft contact lenses to optimize the reducing effect of myopia progression
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To screen the optimal optical design for soft contactlens to prevent progression of myopia
Basic objectives2
Others
Basic objectives -Others
To screen the optimal optical design for soft contactlens to prevent progression of myopia
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amplitude of accommodation
Key secondary outcomes
Lag of accommodation, ANgle of convergence
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Myopia
SCL wearler
Key exclusion criteria
Patients with eye disease other than myopia
HCL wearler
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fujikado |
Organization
Osaka University
Division name
Frontier Bioscinces
Zip code
565-0871
Address
1-3 Yamadaoka, Suita, 565-0871
TEL
06-6879-7995
fujikado@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fujikado |
Organization
Osaka University
Division name
Frontier Bioscinces
Zip code
565-0871
Address
1-3 Yamadaoka, Suita, 565-0871
TEL
06-6879-7995
Homepage URL
fujikado@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Frontier Bioscinces Osaka University
Institute
Department
Personal name
Funding Source
Organization
Frontier Bioscinces Osaka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Commitee Osaka UNiversity MS
Address
2-2 Yamadaoka, Suita
Tel
06-6210-8296
rinri@hp-crc.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
| 2019 | Year | 08 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | 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
By measuring the accommodative amplitude in response to wearing progressive additional SCL with variable additional power and compare that to monofocal SCL, optimal design for preventing myopia progression could be determined
Management information
Registered date
| 2019 | Year | 05 | Month | 29 | Day |
Last modified on
| 2021 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042007
