CataractsNCT01510717

Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

A study testing AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ Monofocal IOL Model SN60WF 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 the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL. 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 Monofocal IOL Model SN60WF
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 409 participants
Where: No sites listed yet
Study dates: Feb 2012to Dec 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

Diagnosis of bilateral cataracts
Willing and able to complete all required postoperative visits
Calculated lens power within the available supply range
Planned cataract removal by phacoemulsification
Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
Preoperative astigmatism less than 1.0 diopter

Show all 10Show fewer

Clear intraocular media other than cataract in study eyes
Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
Other protocol-defined inclusion criteria may apply

Who cannot join

Previous refractive surgery
Inflammation or edema of the cornea
Optic nerve atrophy
Pregnancy
Current participation in another investigational drug or device study
Other protocol-defined exclusion criteria may apply

About this study

Official title: Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2

The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.

Read the detailed description

Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.

Conditions: Cataracts
Being tested: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], AcrySof® IQ Monofocal IOL Model SN60WF
Keywords: Intraocular Lens, Monofocal, Multifocal
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 Monofocal IOL Model SN60WFDevice
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Study groups in NCT01510717
Study group	Role	What they receive
Multifocal IOL	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]
Monofocal IOL	Active comparator	AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation Receives: Device: AcrySof® IQ Monofocal IOL Model SN60WF

What is being measured

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

Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180
Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Measured: Day 120-180 from second eye implantation
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180
Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.
Measured: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation
Photopic Contrast Sensitivity Without Glare at Day 120-180
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Measured: Day 120-180 from second eye implantation
Photopic Contrast Sensitivity With Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Measured: Day 120-180 from second eye implantation
Mesopic Contrast Sensitivity Without Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Measured: Day 120-180 from second eye implantation
Mesopic Contrast Sensitivity With Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Measured: Day 120-180 from second eye implantation

Secondary outcomes (4)

Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180
VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Measured: Day 120-180 from second eye implantation
Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180
VA was tested monocularly (each eye separately) 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, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Measured: Day 120-180 from second eye implantation
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?"
Measured: Day 120-180 from second eye implantation
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?"
Measured: Day 120-180 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.

Feb 2012Dec 2012

First posted16 Jan 2012 (estimated)
Study startFeb 2012
Primary completionDec 2012
Study completionDec 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.
Publications (1)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 409 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01510717
Sponsor's protocol ID: C-10-016
Status last verified: May 2015
First submitted: 12 Jan 2012
Last updated: 27 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Williams JR, Kim HW, Crespi CM. Modeling observations with a detection limit using a truncated normal distribution with censoring. BMC Med Res Methodol. 2020 Jun 29;20(1):170. doi: 10.1186/s12874-020-01032-9.
PubMed 32600261

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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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2
ClinicalTrials.gov ID: NCT01510717
Acronym / sponsor ID: C-10-016
Conditions: Cataracts
Keywords: Intraocular Lens, Monofocal, Multifocal
Study type: Interventional
Recruitment status: Completed
Enrolment: 409 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 16 Jan 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.

The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Multifocal IOL	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
Monofocal IOL	Active comparator	Device: AcrySof® IQ Monofocal IOL Model SN60WFAcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation

Who may qualify

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

Key inclusion criteria (10 listed)

Diagnosis of bilateral cataracts
Willing and able to complete all required postoperative visits
Calculated lens power within the available supply range
Planned cataract removal by phacoemulsification
Potential postoperative visual acuity of 0.2 logMAR or better in both eyes

Key exclusion criteria (6 listed)

Previous refractive surgery
Inflammation or edema of the cornea
Optic nerve atrophy
Pregnancy
Current participation in another investigational drug or device study

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	Multifocal IOL
AcrySof® IQ Monofocal IOL Model SN60WFMonofocal IOL implanted for long-term use over the lifetime of the cataract patient	Device	Monofocal IOL

Primary outcome

Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180
Time frame: Day 120-180 from second eye implantation
Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180
Time frame: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation
Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.
Photopic Contrast Sensitivity Without Glare at Day 120-180
Time frame: Day 120-180 from second eye implantation
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Photopic Contrast Sensitivity With Glare at Day 120-180
Time frame: Day 120-180 from second eye implantation
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Mesopic Contrast Sensitivity Without Glare at Day 120-180
Time frame: Day 120-180 from second eye implantation
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Mesopic Contrast Sensitivity With Glare at Day 120-180
Time frame: Day 120-180 from second eye implantation
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

4 secondary outcomes

Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180
Time frame: Day 120-180 from second eye implantation
Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180
Time frame: Day 120-180 from second eye implantation
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Time frame: Day 120-180 from second eye implantation
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Time frame: Day 120-180 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
Multifocal IOL	155	153
Monofocal IOL	165	160

Primary outcome: Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180

Time frame: Day 120-180 from second eye implantation. Mean (Standard Error). Unit: logMAR

Measure	Multifocal IOL n = 155	Monofocal IOL n = 165
Value	0.322 (0.014)	0.512 (0.013)

Population analysed: This analysis population includes all participants with successful IOL implantation in the primary eye.

Primary outcome: Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180

Time frame: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation. Number. Unit: adverse events

Measure	Multifocal IOL n = 155
Cystoid macular oedema (cumulative)	4
Endophthalmitis (cumulative)	0
Hypopyon (cumulative)	0
Lens dislocated from posterior (cumulative)	0
Pupillary block (cumulative)	0
Retinal detachment (cumulative)	0
Secondary surgical intervention (cumulative)	0
Corneal stroma oedema (persistent)	0

Population analysed: This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye).

Primary outcome: Photopic Contrast Sensitivity Without Glare at Day 120-180

Time frame: Day 120-180 from second eye implantation. Mean (Standard Deviation). Unit: logMAR

Measure	Multifocal IOL n = 133	Monofocal IOL n = 137
3 cpd (n=131,133)	1.676 (0.259)	1.743 (0.203)
6 cpd (n=130,133)	1.816 (0.256)	1.938 (0.251)
12 cpd (n=129,132)	1.460 (0.312)	1.555 (0.312)
18 cpd (n=130,131)	0.970 (0.348)	1.109 (0.325)

Population analysed: The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.

Primary outcome: Photopic Contrast Sensitivity With Glare at Day 120-180

Time frame: Day 120-180 from second eye implantation. Mean (Standard Deviation). Unit: logMAR

Measure	Multifocal IOL n = 133	Monofocal IOL n = 137
3 cpd (n=130,131)	1.608 (0.307)	1.692 (0.274)
6 cpd (n=117,125)	1.684 (0.316)	1.844 (0.309)
12 cpd (n=117,127)	1.334 (0.321)	1.475 (0.336)
18 cpd (n=119,128)	0.914 (0.333)	1.043 (0.361)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-Treatment	1 of 409 (0.2%)	0 of 409 (0%)	Not reported
Multifocal IOL	10 of 155 (6.5%)	0 of 155 (0%)	Not reported
Monofocal IOL	15 of 165 (9.1%)	0 of 165 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32600261Williams JR, Kim HW, Crespi CM. Modeling observations with a detection limit using a truncated normal distribution with censoring. BMC Med Res Methodol. 2020 Jun 29;20(1):170. doi: 10.1186/s12874-020-01032-9.

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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 Monofocal IOL Model SN60WF 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 10 inclusion and 6 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 27 May 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?

Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 (time frame: Day 120-180 from second eye implantation). The study lists 6 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 NCT01510717, which also lists 1 linked publication.

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 27 May 2015.