UMIN-CTR Clinical Trial

Public title

A Study of Visual Performance after Implantation of the Acrylic Toric IOL

Acronym

A Study of Visual Performance after Implantation of the Acrylic Toric IOL

Scientific Title

A Study of Visual Performance after Implantation of the Acrylic Toric IOL

Scientific Title:Acronym

A Study of Visual Performance after Implantation of the Acrylic Toric IOL

Region

Japan

Condition

senile (age-related) cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The study is to be performed for the assessment of the postoperative visual performance and intracapsular stability of acrylic toric IOLs, Models SN6AT3, SN6AT4, and SN6AT5 (tinted aspheric) as well as the comparative assessment of the astigmatism attenuating effects in comparison with the control tinted acrylic aspheric IOL, Model SN60WF (non-toric). And, to confirm the postoperative visual performance which put SN6AT3~5 into the patients with astigmatism is the same as the postoperative visual performance which put SN60WF into the patients without astigmatism.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety
Calculate the number of patients (eyes) with AEs and the incidence rate. Also assess ophthalmic findings, posterior capsulectomy, IOL findings, IOL deflection, intraocular pressure, presence or absence of secondary surgery, corneal endothelial cell count, and flare as the safety endpoints.

Efficacy
Calculate the descriptive statistics of the mean of each data at the prescribed examination/observation time according to the stratification by the IOL and the marking method as well as the number of patients (eyes) and the incidence rate according to the following classifications.

Primary endpoints
Distance visual acuity, subjective cylinder power, IOL decentration/ rotation (angle of toric mark)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

acrylic toric IOLs, Models SN6AT3

Interventions/Control_2

acrylic toric IOLs, Models SN6AT4

Interventions/Control_3

acrylic toric IOLs, Models SN6AT5

Interventions/Control_4

tinted acrylic aspheric IOL, Model SN60WF

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who intend to undergo cataract surgery by ultrasonic phacoemulsification (with aspiration).

2) Patients whose calculated lens frequency is within the lens frequency of the investigational eye.

3) Patients expected to achieve postoperative distant corrected vision of not less than 0.7.

4) Patients expected to achieve normal vision.

5) Toric IOL treatment group: Patients whose preoperative corneal astigmatism of the surgical eye is not more than 3.0 D and who are assessed treatable with SN6AT3, SN6AT4, and SN6AT5 based on the data obtained from the calculation using the toric calculator.

Control IOL treatment group: Patient whose preoperative corneal astigmatism of the surgical eye is not more than 1.5D.

6) Patients who have no opacification in the optic media other than the lens (cataract).

7) Patients who understand the informed consent document and are able to give their consent.

8) Patients anticipated to undergo postoperative follow- up as instructed by the investigator.

Key exclusion criteria

Preoperative

1)Patients with poorly controlled glaucoma.

2)Patients with progressive diabetic retinopathy.

3)Patients with active uveritis.

4)Patients with angiogenesis of iris.

5)Patients with retinal detachment.

6)Patients with abnormal aberration including corneal astigmatism.

7)Patients with past history of corneal refractive surgery.

8)Patients with corneal degeneration such as Fuchs's corneal degeneration.

9)Patients with past history of corneal transplantation.

10)Patients not adequately assessable by funduscopy due to severe preoperative lens opacification.

11)Patients having any disease or using any drug potentially affecting visual acuity.

12)Patients undergoing secondary placement.

13)Pregnant or potentially pregnant or lactating patients.

14)Patients who have participated in any other clinical study (drug or medical device) within 3 months before participation in this clinical study or who intend to participate in any other clinical study during participation in this clinical study.

15)Patients with amydriasis which prevents the investigator from reading the toric marker on the IOL surface even using a mydriatic.

16)Other patients disqualified by the investigator.

Intraoperative

1)Patients who intend to undergo any other ophthalmic surgery (e.g. LASIK, corneal incision for astigmatism correction).

2)Patients who need mechanical or surgical procedures for pupillary dilatation.

3)Patients with massive vitreous loss.

4)Patients with massive anterior chamber bleeding.

5)Patients who have uncontrollable
variation of intraocular pressure.

6)Patients who have a rupture of Zinn's zonule.

7)Patients with pseudo-exfoliation syndrome.

8)Patients who can not undergo intracapsular fixation because of the location of IOL haptic.

Note: Patients considered to have dislocation of the IOL when the investigator assesses the stability of the IOL for Zinn's zonule,

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Kazunori Miyata

Organization

Medical corporation
(meiwakai)

Division name

Miyata Ophthalmic Hospital

Zip code

Address

6-3,kurahara-cho,miyakonojo-city,miyazakiken

TEL

-

Email

-@-

Name of contact person

1st name
Middle name
Last name

Organization

QOL RD Co.,Ltd.

Division name

EBM Division

Zip code

Address

http://www.qol-rd.co.jp

TEL

03-5777-1001

Homepage URL

Email

-@-

Institute

Preventive Medicine Foundation (Yoboigaku Jigyo Chuokai)

Institute

Department

Personal name

Organization

Preventive Medicine Foundation (Yoboigaku Jigyo Chuokai)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

09

Month

08

Day

Date of IRB

Anticipated trial start date

2011

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

06

Month

28

Day

Last modified on

2017

Year

01

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009691