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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036881
Receipt No. 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 2019/12/04

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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
Email 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
Email fujikado@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Frontier Bioscinces Osaka University
Institute
Department

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
Email 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
2021 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
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042007

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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