UMIN-CTR Clinical Trial

Basic information
Public title	AcrySof Toric IQ A-code Post-Market Clinical Study
Acronym	AcrySof Toric IQ Post-Market Clinical Study
Scientific Title	AcrySof Toric IQ A-code Post-Market Clinical Study
Scientific Title:Acronym	AcrySof Toric IQ Post-Market Clinical Study
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Percentage of patients with absolute value of IOL rotation of less than 10 degrees at Visit 4 from Visit 00 IOL rotation is defined as the IOL axis difference between study visits. A photograph of the eye will be taken, and IOL rotation will be calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)] 2. Percentage of patients with absolute value of IOL rotation of less than 20 degrees at Visit 4 from Visit 00 [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)] 3. Percentage of patients with absolute value of IOL rotation of less than 30 degrees at Visit 4 from Visit 00 [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)]
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	AcrySof IQ Toric A-code IOL Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient
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	Not applicable
Gender	Male and Female
Key inclusion criteria	-Diagnosis of cataracts with planned cataract removal by phacoemulsification -Calculated lens power within the available range -Able to sign informed consent and complete all study visits -Other protocol-defined inclusion criteria may apply.
Key exclusion criteria	-Eye conditions as specified in the protocol -Uncontrolled glaucoma -Pregnancy, current or planned -Other protocol-defined exclusion criteria may apply.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Kazunori Middle name Last name Miyata
Organization	Miyata Eye Hospital
Division name	Ophthalmology
Zip code	885-0051
Address	6-3 Kurahara-cho, Miyakonojyo, Miyazaki
TEL	0986-22-1441
Email	kmiyata@miyata-med.ne.jp

Public contact
Name of contact person	1st name Mayu Middle name Last name Saito
Organization	Alcon Japan Ltd.
Division name	Clinical Development
Zip code	105-6333
Address	1-23-1 Toranomon, Minato-ku, Tokyo
TEL	03-6899-5061
Homepage URL
Email	clinicalstudy.japan@alcon.com

Sponsor
Institute	Alcon Japan Ltd.
Institute
Department

Funding Source
Organization	Alcon Japan Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Network Fukuoka Certified Review Board
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka
Tel	092-643-7171
Email	mail@crnfukuoka.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT03350503
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2	jRCTs072180020
Org. issuing International ID_2	jRCT
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	121
Results	Only one subject had an absolute IOL rotation of over 10 degrees at Visit 4. The results of percentages of each category (< 10 degrees, < 20 degrees, < 30 degrees) were greater than performance targets in ISO (EN ISO 11979-7:2014).
Results date posted	2020 Year 07 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Sex [n (%)] Male: 54 subjects (44.6%), Female: 67 subjects (55.4%) Age [mean (standard deviation, SD)] 75.5 (7.0) years old Intraocular lens (IOL) model [n (%)] SN6AT3: 61 subjects (50.4%), SN6AT4: 27 subjects (22.3%), SN6AT5: 33 subjects (27.3%)
Participant flow
Adverse events	<Ocular Adverse Events: 68 events of 49 eyes (20.2%) > There were no ocular adverse events that led to discontinuation of the study. Ocular serious adverse event (ocular SAE): 2 events of 2 eyes (0.8%) [Breakdown] Dermatochalasis (n=2) These were assessed not related to the test article and considered not related to the conduct of this clinical study by the principal investigator. Serious disease or the like: 0 Disease or the like: 2 events of 2 eyes (0.8 %) [Breakdown] Astigmatism (n=1), Photophobia (n=1) There were no disease or the like that led to discontinuation of the study. <Nonocular adverse events: 26 events of 21 subjects (17.4%)> These nonocular adverse events were assessed not related to the test article and considered not related to the conduct of this clinical study by the principal investigator. Nonocular SAEs: 15 events of 19 subjects (12.4%) Study Discontinuation due to nonocular adverse events: 5 of 6 subjects [Breakdown] Deaths: 4 of 5 subjects (Hepatic cancer, Cardiac failure, Pancreatic carcinoma, Lung neoplasm malignant*, Pneumonia*) * in the same subjects Unconscious: 1 of 1 subjects (Brain neoplasm) <Device Deficiencies> IOL rotation: 2 eyes (1.7%) There were no device deficiencies that led to discontinuation of the study.
Outcome measures	- Percentage of patients with absolute value of IOL rotation of less than 10 degrees at Visit 4 from Visit 00 IOL rotation is defined as the IOL axis difference between study visits. A photograph of the eye will be taken, and IOL rotation will be calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)] - Percentage of patients with absolute value of IOL rotation of less than 20 degrees at Visit 4 from Visit 00 [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)] - Percentage of patients with absolute value of IOL rotation of less than 30 degrees at Visit 4 from Visit 00 [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)]
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 21 Day
Date of IRB	2017 Year 10 Month 26 Day
Anticipated trial start date	2018 Year 01 Month 31 Day
Last follow-up date	2021 Year 12 Month 17 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 01 Month 17 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035219