UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of cataract treatment result using multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric
Acronym	Evaluation of postoperative result of multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric
Scientific Title	Evaluation of cataract treatment result using multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric
Scientific Title:Acronym	Evaluation of postoperative result of multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric
Region	Japan

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

Objectives
Narrative objectives1	To evaluate cataract treatment result of cases which multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric were implanted.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Study of visual acuity test (distance of 5m, 70cm, and 40cm) 1 week, 1 month, 3 months, and 6 months after the surgery, objective and subjective refractive value, survey evaluation (glare, halo, etc.) intraocular pressure, and corneal endothelial cell count. -For Trinova Toric implantation, astigmatic axis of IOL will be checked 1 month and 3 month after the surgery.
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	1 intraocular lens will be implanted in 1 eye. Eye will be observed for 6 month after the surgery.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric applicant among cataract surgery applicant.
Key exclusion criteria	Fundus disease Glaucoma Corneal irregular astigmatism (including corneal disease such as conical cornea)
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Ichikawa
Organization	Chukyo Eye Clinic
Division name	Vision Research Laboratory
Zip code	456-0032
Address	12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya city, Aichi
TEL	052-883-1543
Email	ichikawa@chukyogroup.jp

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Sakai
Organization	Chukyo Eye Clinic
Division name	Orthoptist
Zip code	456-0032
Address	12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya city, Aichi
TEL	052-883-1543
Homepage URL
Email	sakai@chukyo-eyeclinic.jp

Sponsor
Institute	Chukyo Eye Clinic
Institute
Department

Funding Source
Organization	Chukyo Medical Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chukyo Eye Clinic Yuya Sato Eye Clinic Hoshino Eye Clinic Tomita Eye Clinic Oka Eye Clinic Nagoya Eye Clinic Chayagasaka Eye Clinic Nakamura Eye Clinic Tomiyasu Eye Clinic Okegawa Eye Clinic Kobayashi Eye Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chukyo Medical Co., Ltd. REC
Address	12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya city, Aichi
Tel	052-884-7976
Email	irb@chukyomedical.co.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	2018 Year 04 Month 10 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	0
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	Terminated
Date of protocol fixation	2018 Year 03 Month 31 Day
Date of IRB	2018 Year 03 Month 31 Day
Anticipated trial start date	2018 Year 03 Month 31 Day
Last follow-up date	2021 Year 10 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 10 Day
Last modified on	2021 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036711