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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041819
Receipt No. R000047732
Scientific Title Clinical trial for smartphone-based functional near vision acuity test
Date of disclosure of the study information 2021/01/01
Last modified on 2021/06/18

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Basic information
Public title Clinical trial for smartphone-based functional near vision acuity test
Acronym Smartphone-based functional near vision acuity test
Scientific Title Clinical trial for smartphone-based functional near vision acuity test
Scientific Title:Acronym Smartphone-based functional near vision acuity test
Region
Japan

Condition
Condition Healthy individuals
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to develop a simple and objective measurement for smartphone-based functional near vision acuity as well as explore the severity index and the treatment timing for presbyopia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between subjective symptoms and objective signs of presbyopia
Key secondary outcomes - Validation for smartphone-based functional near vision acuity test
- Relationship between severity of presbyopia and quality of life

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)=> 20 years old
2)individuals who can use a smartphone
3)those with no intraocular/refractive surgical history
4) Best corrected visual acuity => 0.8 bilaterally
5) those obtained informed consent
Key exclusion criteria 1) Participants who had severe visual impairment
2) Those with communication difficulty
3) Those who had difficulty in participation
4) Those who had severe symptoms of dry eye disease
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kazuno
Middle name
Last name Negishi
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3821
Email kazunonegishi@keio.jp

Public contact
Name of contact person
1st name Kazuno
Middle name
Last name Negishi
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3821
Homepage URL
Email kazunonegishi@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University Global Research Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Shonan Keiiku Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Committee
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.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 慶應義塾大学病院(東京都)、湘南慶育病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2021 Year 01 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 Open public recruiting
Date of protocol fixation
2020 Year 09 Month 14 Day
Date of IRB
2020 Year 09 Month 14 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Healthy individuals =>20 years old are included to examine the validity of the smartphone-based functional near vision acuity test as well as the correlation between severity of presbyopia and quality of life by using statistical methods.

Management information
Registered date
2020 Year 09 Month 17 Day
Last modified on
2021 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047732

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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