CataractsNCT01684007

A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients

A study testing AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 in people with Cataracts, run by Alcon Research.

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 compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cataracts
What is being tested?: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: No sites listed yet
Study dates: Nov 2012to Aug 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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing and able to understand and sign informed consent, and attend postoperative examinations per protocol schedule;
Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes;
Willing to have second eye surgery within 45 days of first eye surgery;
Expected postoperative astigmatism < 1.0 D in both eyes, as measured by keratometry;
Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement;
Significant irregular corneal astigmatism as demonstrated by corneal topography;
Severe degenerative visual disorders;
Previous corneal surgery;
Amblyopia;
Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study;

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History of corneal disease;
Severe diabetic retinopathy;
History of retinal detachment;
Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study;
Pregnant or planning pregnancy during course of study;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Clinical Outcomes After Implantation of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (MIOL) in the Dominant Eye and Randomization of the AcrySof® IQ ReSTOR® +2.5 D or +3.0 D MIOL in the Fellow Eye

Read the detailed description

Each subject will complete a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second implantation will occur between 1 and 45 days of the first. If the first eye is not implanted during surgery, the second eye is not eligible. lf both eyes are not implanted with the assigned IOL, the subject will be followed for safety evaluation.

Conditions: Cataracts
Being tested: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Keywords: Intraocular lens, Multifocal intraocular lens (MIOL)
Medical subject headings: Cataract

What participants receive

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

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]Device
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1Device
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

Study groups in NCT01684007
Study group	Role	What they receive
Bilateral	Experimental	AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation Receives: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Contralateral	Active comparator	AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation Receives: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

What is being measured

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

Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
Measured: Day 90 from second eye implantation

Secondary outcomes (1)

Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)
VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
Measured: Day 90 from second eye implantation

Timeline

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

Nov 2012Aug 2013

First posted12 Sep 2012 (estimated)
Study startNov 2012
Primary completionAug 2013
Study completionAug 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.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01684007
Sponsor's protocol ID: M-12-007
Status last verified: May 2015
First submitted: 10 Sep 2012
Last updated: 22 Jun 2015
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?

Official record

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All Cataracts trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes After Implantation of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (MIOL) in the Dominant Eye and Randomization of the AcrySof® IQ ReSTOR® +2.5 D or +3.0 D MIOL in the Fellow Eye
ClinicalTrials.gov ID: NCT01684007
Acronym / sponsor ID: M-12-007
Conditions: Cataracts
Keywords: Intraocular lens, Multifocal intraocular lens (MIOL)
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 12 Sep 2012 (estimated)
Results: Posted 27 May 2015

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: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Bilateral	Experimental	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
Contralateral	Active comparator	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Willing and able to understand and sign informed consent, and attend postoperative examinations per protocol schedule;
Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes;
Willing to have second eye surgery within 45 days of first eye surgery;
Expected postoperative astigmatism < 1.0 D in both eyes, as measured by keratometry;
Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts;

Key exclusion criteria (12 listed)

Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement;
Significant irregular corneal astigmatism as demonstrated by corneal topography;
Severe degenerative visual disorders;
Previous corneal surgery;
Amblyopia;

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® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient	Device	Bilateral, Contralateral
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1Multifocal IOL implanted for long-term use over the lifetime of the cataract patient	Device	Contralateral

Primary outcome

Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
Time frame: Day 90 from second eye implantation
Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

1 secondary outcome

Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)
Time frame: Day 90 from second eye implantation

Results and safety

Results posted to the registry on 27 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bilateral	53	53
Contralateral	50	50

Primary outcome: Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)

Time frame: Day 90 from second eye implantation. Mean (Standard Deviation). Unit: logMAR

Measure	Bilateral n = 53	Contralateral n = 50
Value	0.13 (0.148)	0.09 (0.133)

Population analysed: This analysis population includes all subjects with both eyes implanted.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bilateral	0 of 53 (0%)	3 of 53 (5.7%)	Not reported
Contralateral	2 of 50 (4%)	3 of 50 (6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataracts

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
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.

Magda Michna, PhD study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 in people with Cataracts, run by Alcon Research.

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 6 inclusion and 12 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 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

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 27 May 2015). 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?

Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) (time frame: Day 90 from second eye implantation). 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 NCT01684007.

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 22 Jun 2015.