UMIN-CTR Clinical Trial

Basic information
Public title	Clinical utility of extended depth of focus intraocular lens to expand applying multifocal intraocular lens
Acronym	Clinical utility of extended depth of focus intraocular lens
Scientific Title	Clinical utility of extended depth of focus intraocular lens to expand applying multifocal intraocular lens
Scientific Title:Acronym	Clinical utility of extended depth of focus intraocular lens
Region	Japan

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

Objectives
Narrative objectives1	To evaluate clinical utility of extended depth of focus intraocular lens for eyes with irregular corneal astigmatism and eyes after refractive surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	contrast sensitivity
Key secondary outcomes	conventional visual acuity, functional visual acuity, binocular visual function refraction, high order aberration, light scattering QOL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Patient with extended depth of focus intraocular lens (ZXR00V)
Interventions/Control_2	Patient with monofocal intraocular lens (ZCB00V)
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	Cataract patient with irregular corneal astigmatism or after refractive surgery
Key exclusion criteria	anisometropia, strabismus, dry eye, severe glaucoma, macular disease, optic nerve disease
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yumi Middle name Last name Hasegawa
Organization	University of Tsukuba
Division name	Department of Ophthalmology, Faculty of Medicine,
Zip code	3058575
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL	029-853-3148
Email	ytamura-tuk@umin.ac.jp

Public contact
Name of contact person	1st name Yumi Middle name Last name Hasegawa
Organization	University of Tsukuba
Division name	Department of Ophthalmology, Faculty of Medicine,
Zip code	3058575
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL	029-853-3148
Homepage URL
Email	ytamura-tuk@umin.ac.jp

Sponsor
Institute	Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba Hospital
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	Tsukuba Clinical Research & Development Organization
Address	Amakubo 2-1-1 Tsukuba Ibaraki Japan
Tel	029-853-3914
Email	rinshokenkyu@un.tsukuba.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	2017 Year 12 Month 25 Day

Related information
URL releasing protocol	https://tsukuba-eye.jp
Publication of results	Unpublished

Result
URL related to results and publications	https://tsukuba-eye.jp
Number of participants that the trial has enrolled	4
Results	There was no difference in postoperative contrast sensitivity between the symphony group and the monodical lens group.
Results date posted	2021 Year 01 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with cataract surgery for eyes with corneal astigmatism that is more than twice the standard deviation (2SD) or with a history of refractive surgery
Participant flow	The principal investigator will explain the content of this study and the characteristics of each intraocular lens to the target patients, and the patient will decide which intraocular lens to use.
Adverse events	No
Outcome measures	contrast sensitivity
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 20 Day
Date of IRB	2018 Year 01 Month 05 Day
Anticipated trial start date	2018 Year 01 Month 04 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 22 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034852