UMIN-CTR Clinical Trial

Basic information
Public title	Investigation on cataract treatment result using multi-focal intraocular lens, AcrivaUDReviol Tri-ED and Tri-ED T 611
Acronym	Investigation on postoperative result of multi-focal intraocular lens, AcrivaUDReviol Tri-ED
Scientific Title	Investigation on cataract treatment result using multi-focal intraocular lens, AcrivaUDReviol Tri-ED and Tri-ED T 611
Scientific Title:Acronym	Investigation on postoperative result of multi-focal intraocular lens, AcrivaUDReviol Tri-ED
Region	Japan

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

Objectives
Narrative objectives1	Investigation on cataract treatment result using multi-focal intraocular lens, AcrivaUDReviol Tri-ED and Tri-ED T 611
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Visual test 1week, 1 month, 3 months, 6 months after the surgery (test distance: 5m, 70cm, 40cm), objective and subjective refractive value, questionnaire evaluation (presence of halo or glare), intraocular pressure, number of corneal endothelial cell. -When Tri-ED T 611 is implanted astigmatic axis of the 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	Inserted one piece of intraocular lens per one eye, the observation period is until six months after 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Applicant for multi-focal intraocular lens AcrivaUDReviol Tri-ED and Tri-ED T 611 among cataract surgery applicant.
Key exclusion criteria	Fundus disease Glaucoma Corneal irregular astigmatism (including corneal disease like 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	12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya, 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	12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
TEL	052-883-1543
Homepage URL
Email	sakai@chukyo-eyeclinic.jp

Sponsor
Institute	Chukyo Eye Clinic
Institute
Department

Funding Source
Organization	Self funding
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, 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	2017 Year 08 Month 03 Day

Related information
URL releasing protocol	none
Publication of results	Published

Result
URL related to results and publications	none
Number of participants that the trial has enrolled	20
Results	A relatively good intermediate and near vision were obtained.
Results date posted	2021 Year 03 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Average age was 60.9+-9.7 6 male eyes 14 female eyes Average axial length was 26.23+-2.14mm Preoperative average corneal power was 43.83+-1.44D Average degree of cataract before surgery was 2.60+-0.86 Breakdown of Toric cases: +1.0D (5 eyes) and +1.5D (2 eyes)
Participant flow	20 cases with 20 eyes with the subject intraocular lens (IOL) implantation
Adverse events	none
Outcome measures	Value is average +- standard deviation Uncorrected distance vision-0.09+-0.10 Corrected distance vision-0.17+-0.08 Uncorrected intermediate vision 0.08+-0.12 Distance corrected intermediate vision 0.05+-0.07 Uncorrected near vision 0.14+-0.11 Distance corrected near vision 0.10+-0.08
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB	2017 Year 07 Month 12 Day
Anticipated trial start date	2017 Year 08 Month 03 Day
Last follow-up date	2019 Year 08 Month 05 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 08 Month 03 Day
Last modified on	2021 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032613