A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

A study testing Toric T3 - T9 and IQ SN60WF in people with Cataract, run by Alcon Research.

Completed

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

Trial summary

The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cataract
What is being tested?: Toric T3 - T9 and IQ SN60WF
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Mar 2011to Jun 2012
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 an informed consent;
Willing and able to attend post-operative examinations per protocol schedule;
In good ocular health, with the exception of cataracts;
Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
In good ocular health, with the exception of cataracts;
Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Previous corneal surgery;
Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
Planned multiple procedures during cataract/IOL implantation surgery;
Ocular disease and/or condition that may compromise study results;
Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
Pregnant or planning pregnancy during course of study;
Participation in any other investigational study within 30 days prior to enrolment;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

Conditions: Cataract
Being tested: Toric T3 - T9, IQ SN60WF
Keywords: Intraocular Lens, Toric
Medical subject headings: Cataract

What participants receive

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

Toric T3 - T9Device
Also called AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9
Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient
IQ SN60WFDevice
Also called AcrySof® IQ IOL Model SN60WF
Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient

Study groups in NCT01225926
Study group	Role	What they receive
Toric T3 - T9	Experimental	AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye. Receives: Device: Toric T3 - T9
IQ SN60WF	Active comparator	AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye. Receives: Device: IQ SN60WF

What is being measured

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

Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3
Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.
Measured: Month 3

Timeline

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

Mar 2011Jun 2012

First posted21 Oct 2010 (estimated)
Study startMar 2011
Primary completionJun 2012
Study completionJun 2012

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 CataractStudies 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01225926
Sponsor's protocol ID: M10-003
Status last verified: Sep 2013
First submitted: 20 Oct 2010
Last updated: 29 Oct 2013
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 Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
ClinicalTrials.gov ID: NCT01225926
Acronym / sponsor ID: M10-003
Conditions: Cataract
Keywords: Intraocular Lens, Toric
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 21 Oct 2010 (estimated)
Results: Posted 24 Sep 2013

Clinical summary

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

Study design

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

Arm	Type	Receives
Toric T3 - T9	Experimental	Device: Toric T3 - T9AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
IQ SN60WF	Active comparator	Device: IQ SN60WFAcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.

Who may qualify

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

Key inclusion criteria (8 listed)

Willing and able to understand and sign an informed consent;
Willing and able to attend post-operative examinations per protocol schedule;
In good ocular health, with the exception of cataracts;
Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;

Key exclusion criteria (8 listed)

Previous corneal surgery;
Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
Planned multiple procedures during cataract/IOL implantation surgery;
Ocular disease and/or condition that may compromise study results;
Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;

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
Toric T3 - T9Also: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient	Device	Toric T3 - T9
IQ SN60WFAlso: AcrySof® IQ IOL Model SN60WFCommercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient	Device	IQ SN60WF

Primary outcome

Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3
Time frame: Month 3
Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.

Results and safety

Results posted to the registry on 24 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Toric T3 - T9	12	12
IQ SN60WF	12	12

Primary outcome: Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3

Time frame: Month 3. Mean (Standard Deviation). Unit: logMAR

Measure	Toric T3 - T9 n = 11	IQ SN60WF n = 12
Value	0.089 (0.1212)	0.225 (0.1503)

Population analysed: Per protocol: All subjects who received IOLs in both eyes and followed the protocol with no major protocol deviations.

Adverse events

Time frame: Adverse events were collected for the duration of the study. An adverse event was defined as any untoward medical occurrence in a subject regardless of whether or not the event had a causal relationship with the medical device under investigation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Toric T3 - T9	1 of 12 (8.3%)	0 of 12 (0%)	Not reported
IQ SN60WF	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): This study was considered a pilot study and did not have an expectation to meet any of the study endpoints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Toric T3 - T9 and IQ SN60WF in people with Cataract, 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 8 inclusion and 8 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 29 Oct 2013. 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 24 Sep 2013). 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 Visual Acuity (Monocular UCDVA) at Month 3 (time frame: Month 3). 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 NCT01225926.

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 29 Oct 2013.