UMIN-CTR Clinical Trial

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

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Alcon Japan Ltd.

Institute

Department

Personal name

Organization

Alcon Japan Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

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

Date of disclosure of the study information

2018

Year

01

Month

19

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2018

Year

01

Month

17

Day

Last modified on

2022

Year

11

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035219