CataractsNCT01323777

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan

A study testing AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in people with Cataracts, run by Alcon Research at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace the natural lens in Japanese cataract patients. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Cataracts
What is being tested?: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 2 sitesJapan
Study dates: May 2011to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign informed consent;
Diagnosed with bilateral cataracts;
Planned cataract removal by phacoemulsification;
Potential postoperative visual acuity of 0.6 decimal or better in both eyes;
Preoperative astigmatism ≥ 0.75 diopter;
Clear intraocular media other than cataract in study eyes;

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Calculated lens power and astigmatism within the available range;
Pupil size greater than or equal to 6 mm after dilation;
Able to undergo second eye surgery within 30 days of the first eye surgery;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Irregular corneal aberration as demonstrated by corneal topography;
Any inflammation or edema (swelling) of the cornea;
Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.6 decimal;
Diabetic retinopathy;
Previous refractive surgery, retinal detachment, corneal transplant;
Glaucoma;

Show all 9Show fewer

Pregnant, nursing, or suspected of being pregnant;
Currently participating in another investigational drug or device study;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Tokyo Dental College Suidobashi Hospital
Chiyoda-ku, Tokyo, 101-0061
Hayashi Eye Hospital
Fukuoka, 812-0011

Other trials in Japan

About this study

Official title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6

Read the detailed description

Eligible participants completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits: Day 1-2, Day 7-14, and Day 30-60 after each implantation, and Day 120-180 and Day 330-420 after second eye implantation. The second implantation occurred within 30 days of the first.The primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. If both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.

Conditions: Cataracts
Being tested: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Keywords: Cataracts, Intraocular lens, Multifocal, Toric, Astigmatism, Presbyopia
Medical subject headings: Cataract, Astigmatism, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOLDevice
Also called Models SND1T3, SND1T4, SND1T5, SND1T6
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Study groups in NCT01323777
Study group	Role	What they receive
ReSTOR +3.0	Experimental	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation Receives: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

What is being measured

The primary outcome is the main question the study is designed to answer.

Monocular Uncorrected Distance Decimal Visual Acuity
Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Measured: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Monocular Uncorrected Near Decimal VA
VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Measured: Day 30-60, Day 120-180, Day 330-420

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Mar 2013

First posted28 Mar 2011 (estimated)
Study startMay 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01323777
Sponsor's protocol ID: J-10-050
Status last verified: Mar 2017
First submitted: 24 Mar 2011
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataracts trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
ClinicalTrials.gov ID: NCT01323777
Acronym / sponsor ID: J-10-050
Conditions: Cataracts
Keywords: Cataracts, Intraocular lens, Multifocal, Toric, Astigmatism, Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 28 Mar 2011 (estimated)
Results: Posted 6 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ReSTOR +3.0	Experimental	Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOLAcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Sign informed consent;
Diagnosed with bilateral cataracts;
Planned cataract removal by phacoemulsification;
Potential postoperative visual acuity of 0.6 decimal or better in both eyes;
Preoperative astigmatism ≥ 0.75 diopter;

Key exclusion criteria (9 listed)

Irregular corneal aberration as demonstrated by corneal topography;
Any inflammation or edema (swelling) of the cornea;
Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.6 decimal;
Diabetic retinopathy;
Previous refractive surgery, retinal detachment, corneal transplant;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOLAlso: Models SND1T3, SND1T4, SND1T5, SND1T6Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient	Device	ReSTOR +3.0

Primary outcome

Monocular Uncorrected Distance Decimal Visual Acuity
Time frame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Monocular Uncorrected Near Decimal VA
Time frame: Day 30-60, Day 120-180, Day 330-420
VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

Results and safety

Results posted to the registry on 6 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ReSTOR +3.0	65	65

Primary outcome: Monocular Uncorrected Distance Decimal Visual Acuity

Time frame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420. Number. Unit: participants

Measure	Day 1-2 n = 65	Day 7-14 n = 65	Day 30-60 n = 65	Day 120-180 n = 65	Day 330-420 n = 65
Primary eye worse than 0.5 decimal	3	3	1	0	1
Primary eye 0.5 to less than 0.7 decimal	12	4	6	3	5
Primary eye 0.7 to less than 1.0 decimal	29	27	30	27	28
Primary eye 1.0 decimal or better	21	31	28	35	31
Secondary eye worse than 0.5 decimal	5	1	3	1	0
Secondary eye 0.5 to less than 0.7 decimal	14	7	2	6	6
Secondary eye 0.7 to less than 1.0 decimal	21	22	28	28	27
Secondary eye 1.0 decimal or better	25	35	32	30	32

Population analysed: This analysis population includes all implanted subjects.

Primary outcome: Monocular Uncorrected Near Decimal VA

Time frame: Day 30-60, Day 120-180, Day 330-420. Number. Unit: participants

Measure	Day 30-60 n = 65	Day 120-180 n = 65	Day 330-420 n = 65
Primary eye worse than 0.4 decimal	1	0	1
Primary eye 0.4 decimal or better	64	65	64
Secondary eye worse than 0.4 decimal	1	1	0
Secondary eye 0.4 decimal or better	64	64	65

Population analysed: This analysis population includes all implanted subjects.

Adverse events

Time frame: This reporting group includes all implanted subjects.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ReSTOR +3.0	8 of 65 (12.3%)	0 of 65 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataracts

RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Group Manager, Surgical study director

Alcon Japan, Ltd.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in people with Cataracts, run by Alcon Research at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monocular Uncorrected Distance Decimal Visual Acuity (time frame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01323777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.