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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040418
Receipt No. R000046123
Scientific Title An examination of the relationship between functional visual acuity and contact lens wettability while wearing multifocal soft contact lens
Date of disclosure of the study information 2020/05/16
Last modified on 2020/05/16

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Basic information
Public title An examination of the relationship between functional visual acuity and contact lens wettability while wearing multifocal soft contact lens
Acronym An examination of the relationship between functional visual acuity and contact lens wettability with multifocal SCL
Scientific Title An examination of the relationship between functional visual acuity and contact lens wettability while wearing multifocal soft contact lens
Scientific Title:Acronym An examination of the relationship between functional visual acuity and contact lens wettability with multifocal SCL
Region
Japan

Condition
Condition Patients who are aware of a decline in visual acuity of 45 years or older
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the relationship between functional visual acuity and contact lens wettability of multifocal soft contact lenses and the factors that related to decreased practical vision, including patient satisfaction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparative evaluation of examination during wearing of two kinds of soft contact lenses
Key secondary outcomes

Base
Study type Observational

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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who are aware of a decline in visual acuity of 45 years or older
2. Single focal soft contact lens wearer who wants multifocal soft contact lens
3. Patients with distant Orthodontic visual of 0.8 or more
4. Patients who understand the contents of the consent document and are able to consent in the document of the person
5. Patients who can come to the observation day by the instruction of the researchers
Key exclusion criteria 1. Patients who may affect the orthodontic vision of contact lenses due to diseases such as keratoconus, ptosis and dry eye
2. Patients who have allergy and infectious ocular conditions.
3. Patients who have been deemed unfit for the incorporate of this research by research managers or researchers
4. Patients judged by research managers or researchers as inappropriate to implement this research safety
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Suzuki
Organization Ishizuchi Eye Clinic
Division name Chairman
Zip code 792-0811
Address 1-8-30 Shonaicho Niihama-city Ehime
TEL 0897333069
Email t-suzuki@ishizuchi-eye-clinic.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Suzuki
Organization Ishizuchi Eye Clinic
Division name Chairman
Zip code 792-0811
Address 1-8-30 Shonaicho Niihama-city Ehime
TEL 0897333069
Homepage URL
Email t-suzuki@ishizuchi-eye-clinic.jp

Sponsor
Institute Ishizuchi Eye Clinic
Institute
Department

Funding Source
Organization Alcon Japan Ltd
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 Kyoyukai RiverSide Clinic
Address 2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel 011-521-2321
Email rinrishinsa@riversideclinic.or.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
2020 Year 05 Month 16 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 Open public recruiting
Date of protocol fixation
2020 Year 01 Month 06 Day
Date of IRB
2020 Year 01 Month 29 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information *

Management information
Registered date
2020 Year 05 Month 16 Day
Last modified on
2020 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046123

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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