UMIN-CTR Clinical Trial

Basic information
Public title	Japanese version QOV questionnaire pilot study
Acronym	Japanese version QOV questionnaire pilot study
Scientific Title	Japanese version QOV questionnaire pilot study
Scientific Title:Acronym	Japanese version QOV questionnaire pilot study
Region	Japan

Condition
Condition	Patient who recieved cataract surgery and were impalnted with multifocal intraocular lens
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To conduct a pilot study of the Japanese version of the QOV questionnaire
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examination time, biased response, patient response, examiner's impression
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient after cataract surgery implanted with multifocal intraocular lens
Key exclusion criteria	Other eye disease
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Santaro Middle name Noguchi Last name Noguchi
Organization	Tsukazaki Hospital
Division name	Ophthalmology
Zip code	671-1227
Address	Waku, 68-1
TEL	09037507658
Email	n_santa_pl0_0lq@hotmail.com

Public contact
Name of contact person	1st name Santaro Middle name Noguchi Last name Noguchi
Organization	Tsukazaki Hospital
Division name	Ophthalmology
Zip code	671-1227
Address	Waku, 68-1
TEL	09037507658
Homepage URL
Email	n_santa_pl0_0lq@hotmail.com

Sponsor
Institute	Tsukazaki Hospital
Institute
Department

Funding Source
Organization	Tsukazaki Hospital
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	Tsukazaki Hospital
Address	Waku, 68-1
Tel	+819037507658
Email	n_santa_pl0_0lq@hotmail.com

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 04 Month 20 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	2020 Year 04 Month 05 Day
Date of IRB	2020 Year 03 Month 05 Day
Anticipated trial start date	2020 Year 04 Month 05 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation study

Management information
Registered date	2020 Year 04 Month 05 Day
Last modified on	2020 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045683