UMIN-CTR Clinical Trial

Basic information
Public title	Study of the presence or absence of presbyopia and the effects of the presence of presbyopia on the quality of everyday life
Acronym	Study of the actual conditions of presbyopia
Scientific Title	Study of the presence or absence of presbyopia and the effects of the presence of presbyopia on the quality of everyday life
Scientific Title:Acronym	Study of the actual conditions of presbyopia
Region	Japan

Condition
Condition	presbyopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the presence or absence of presbyopia and the effects of the presence of presbyopia on the quality of everyday life
Basic objectives2	Others
Basic objectives -Others	To build the criteria for intervention by this study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective symptoms of presbyopia, subjective sense of well-being, quality of sleep, refraction value, far and near (40cm) vision, binocular far and near (40cm) vision (under daily correction state)
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	Other
Interventions/Control_1	Questionnaire
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	Patients age of 20 years old or more. Admitted to ophthalmology clinic. Practice on, it is determined that the required. Patients who are decided that refractive tests and vision tests are necessary for their medical examination and undergo refractive and vision tests. Corrected visual acuity of 0.8 and over
Key exclusion criteria	Patients who underwent refractive surgery. Patients who are judged to be inappropriate as a cooperator by various situations such as the patients can't undergo correct tests or reply the questionnaire because of the drops of the cognitive function.
Target sample size	200

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	Shinanomachi 35, Shinjuku-ku, Tokyo Japan
TEL	81333598302
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	Shinanomachi 35, Shinjuku-ku, Tokyo Japan
TEL	81333598302
Homepage URL
Email	kazunonegishi@keio.jp

Sponsor
Institute	Keio university school of medicine
Institute
Department

Funding Source
Organization	Keio university school of medicine
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	Keio University School of Medicine Ethics Committee
Address	Shinanomachi 35, 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	南青山アイクリニック（東京都）、クイーンズ・アイクリニック（神奈川県）、湘南慶育病院（神奈川県）、慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	70
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	Completed
Date of protocol fixation	2016 Year 01 Month 19 Day
Date of IRB	2015 Year 11 Month 11 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	cross-sectional method Include patients satisfy the inclusion criteria and consent to join this study.

Management information
Registered date	2016 Year 03 Month 23 Day
Last modified on	2022 Year 10 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023818