UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Visual Impairment on Quality of Life by Eye Disease in Japan
Acronym	Effect of Visual Impairment on Quality of Life by Eye Disease in Japan
Scientific Title	Effect of Visual Impairment on Quality of Life by Eye Disease in Japan
Scientific Title:Acronym	Effect of Visual Impairment on Quality of Life by Eye Disease in Japan
Region	Japan

Condition
Condition	retinal pigmentosa, age-related macular degeneration, corneal degeneration, severe diabetic retinopathy, glaucoma, cataract, and 50 healthy individuals as controls.
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate the Japanese-version of the impact of vision impairment (IVI), a vision-related quality of life (VRQoL) questionnaire and evaluate the impact of VI and ocular pathologies using the Japanese IVI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the impact of vision impairment (IVI)
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Visually impaired patients aged 20 years and older (good visual acuity in one eye is less than 0.5) who visit our ophthalmology clinic.
Key exclusion criteria	Developmental abnormalities, behavioral disorders, and dementia cases that make vision screening difficult
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Saiko Middle name Last name Matsumura
Organization	Toho University School of Medicine
Division name	Department of Ophthalmology
Zip code	143-8541
Address	6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan
TEL	0337624151
Email	saiko.matsumura@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Saiko Middle name Last name Matsumura
Organization	Toho University School of Medicine
Division name	Department of Ophthalmology
Zip code	143-8541
Address	6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan
TEL	0337624151
Homepage URL
Email	saiko.matsumura@med.toho-u.ac.jp

Sponsor
Institute	Toho University School of Medicine
Institute
Department

Funding Source
Organization	Toho University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Toho University School of Medicine
Address	6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan
Tel	0337624151
Email	saiko.matsumura@med.toho-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	2021 Year 07 Month 14 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	2021 Year 04 Month 01 Day
Date of IRB	2021 Year 06 Month 24 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	International Collaborative Research

Management information
Registered date	2021 Year 07 Month 14 Day
Last modified on	2021 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051237