UMIN-CTR Clinical Trial

Public title

Corrected VA with Long Term Follow up
after AcrySof IOL Implantation

Acronym

Corrected VA with Long Term Follow up
after AcrySof IOL Implantation

Scientific Title

Corrected VA with Long Term Follow up
after AcrySof IOL Implantation

Scientific Title:Acronym

Corrected VA with Long Term Follow up
after AcrySof IOL Implantation

Region

Japan

Condition

Cataract

Classification by specialty

Ophthalmology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To demonstrate non-inferiority of AcrySof (acrylic) to control IOLs (silicone and PMMA) in BCVA change at the long-term post-implantation (implantation period is 1994 to 2000) visit.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

BCVA change at the long term post implantation visit from within 3 months after IOL implantation

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

AcrySof group

Interventions/Control_2

PMMA group

Interventions/Control_3

Slicone group

Interventions/Control_4

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)Willing to provide voluntary consent and able to comprehend and sign the informed consent form
2)Pseudophakic patients who were implanted with an Acrylic (AcrySof), PMMA or silicone IOL from 1994 to 2000.
3)Clear intraocular media in study eyes
4)Best corrected visual acuity (decimal) within 3 months post implantation is 0.8 (decimal VA chart) or more in study eye.
5)Patient who does not have an ocular or systemic condition which may affect visual acuity in study eye.

Key exclusion criteria

1)Patient who has the following complications that may have an impact on visual acuity at the time of the prospective visit in study eye.
-Glaucoma
-Diabetic retinitis
-Ocular inflammatory disease; scleritis, uveitis, herpes corneae, etc.
-Retinal detachment
-Abnormal retina and fovea; Macular degeneration, retinal disease
-Corneal disease, corneal endothelial cell loss, etc.
-History of keratoplasty
-Ocular trauma
-Intraocular surgery post IOL implantation Occur with post capsular Opacification. Eyes that had YAG laser performed or with peripheral opacification (outside the photopic pupil size) will be allowed in the study
2)Previous refractive surgery in study eye
3)Previous IOL exchange in study eye
4)Disqualified by the investigator or the sub investigator because of systemic or ophthalmic diseases

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	Kazunori Miyata

Organization

Miyata Eye Hospital

Division name

Miyata Eye Hospital

Zip code

Address

6-3 Kurahara Miyakonojo Miyazaki

TEL

0986-22-1441

Email

miyata@miyata-med.ne.jp

Name of contact person

1st name
Middle name
Last name	Koji Hasegawa

Organization

Alcon Japan Ltd.

Division name

Clinical Development, Clinical & Regulatory Affairs

Zip code

Address

1-23-1 Toranomon, Minato-ku, Tokyo

TEL

03-6899-5061

Homepage URL

Email

koji.hasegawa@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

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

2015

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

The mean change in logMAR best-corrected visual acuity from baseline at the long-term post-implantation follow-up visit was 0.01, 0.04, and -0.01 in the AcrySof, silicone, and PMMA groups, respectively. The upper limit of 97.5% one-sided confidence interval of the difference in the change in best-corrected visual acuity between the AcrySof group and each control group was +0.01 logMAR for the silicone group and +0.07 logMAR for the PMMA group, both of which were lower than the non-inferiority margin of +0.1 logMAR.

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

2015

Year

03

Month

30

Day

Date of IRB

Anticipated trial start date

2015

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective adverse events were observed in the target eye for efficacy analysis of 1 subject (3.2%) in the AcrySof group and in the contralateral eye of 1 subject (3.3%) in the PMMA group. None of these events were considered to be related to the IOL.
Retrospective adverse events were observed in 1 subject (3.2%) in the AcrySof group, 3 subjects (8.1%) in the silicone group, and 4 subjects (13.3%) in the PMMA group. None of these events were considered to be related to the IOL.
A retrospective adverse reaction was observed in 1 subject (2.7%) in the silicone group. The causal relationship between this event and the IOL was considered unknown by the investigator, and the event was therefore classified as an adverse reaction.
No device failures were observed.

Registered date

2015

Year

05

Month

28

Day

Last modified on

2016

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020520