CataractsNCT01424189

Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

A study testing AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL and AcrySof® ReSTOR® Multifocal IOL Model SA60D3 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 evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal 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® +3.0 D Multifocal Toric IOL and AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 677 participants
Where: No sites listed yet
Study dates: Jul 2011to Jan 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

Diagnosed with bilateral cataracts;
Able to comprehend and sign a statement of informed consent;
Calculated lens power and astigmatism within the available range;
Willing and able to complete all required postoperative visits;
Planned cataract removal by phacoemulsification;
Potential postoperative visual acuity of 0.2 logMAR or better in both eyes;

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Preoperative astigmatism in both operative eyes as described in the clinical protocol; Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.
Clear intraocular media other than cataract in study eyes;
Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR in each eye;
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-specified inclusion criteria may apply.

Who cannot join

Significant irregular corneal aberration as demonstrated by corneal topography;
Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism;
Any inflammation or edema (swelling) of the cornea;
Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.2 logMAR;
Reasonably expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy);
Previous corneal refractive surgery;

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Amblyopia;
Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
Diabetic retinopathy;
Extremely shallow anterior chamber, not due to swollen cataract;
Microphthalmos;
Previous retinal detachment;
Previous corneal transplant;
Recurrent severe anterior or posterior segment inflammation of unknown etiology;
Rubella or traumatic cataract;
Iris neovascularization;
Glaucoma (uncontrolled or controlled with medication);
Aniridia;
Optic nerve atrophy;
Pregnancy;
Current participation in another investigational drug or device study that may confound the results of this investigation;
Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions, for the duration of the study;
Other protocol-specified exclusion criteria may apply.

About this study

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

The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.

Read the detailed description

Participants 21 years and older within the targeted astigmatism range and in need of cataract extraction in both eyes were consented and randomized in a 2:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® Multifocal Toric IOL or the control AcrySof® ReSTOR® Multifocal IOL in both eyes. Each participant completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60 and binocular testing at Day 120-180 and Day 340-420/Visit 5 following the second implantation. The eye with the greater amount of astigmatism was implanted first (first operative eye). The second eye implant was intended to occur within 30 days after the first eye implant but not prior to 7 days after the first eye implant. Both eyes needed to qualify under inclusion/exclusion criteria at the preoperative visit. If the first eye was excluded during surgery, the second eye was not eligible. If the second eye was excluded during surgery, only the first eye was followed.

Conditions: Cataracts
Being tested: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Keywords: Cataract surgery, Intraocular lens
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® +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
AcrySof® ReSTOR® Multifocal IOL Model SA60D3Device
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient

Study groups in NCT01424189
Study group	Role	What they receive
ReSTOR Toric IOL	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
ReSTOR IOL	Active comparator	AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation Receives: Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3

What is being measured

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

Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5
Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. 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 first operative eye.
Measured: Month 12 from second eye implantation
Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5
VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. 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 first operative eye.
Measured: Month 12 from second eye implantation
Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5
The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.
Measured: Month 12 from second eye implantation

Secondary outcomes (1)

Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from "never" to "always" (frequency) or "none" to "severe" (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score "severe" for the visual phenomenon.
Measured: Month 12 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.

Jul 2011Jan 2013

First posted26 Aug 2011 (estimated)
Study startJul 2011
Primary completionJan 2013
Study completionJan 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.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 677 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01424189
Sponsor's protocol ID: C-09-036
Status last verified: May 2018
First submitted: 25 Aug 2011
Last updated: 29 Jun 2018
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 29 Jun 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: NCT01424189
Acronym / sponsor ID: C-09-036
Conditions: Cataracts
Keywords: Cataract surgery, Intraocular lens
Study type: Interventional
Recruitment status: Completed
Enrolment: 677 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 26 Aug 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.

The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ReSTOR Toric IOL	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
ReSTOR IOL	Active comparator	Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation

Who may qualify

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

Key inclusion criteria (12 listed)

Diagnosed with bilateral cataracts;
Able to comprehend and sign a statement of informed consent;
Calculated lens power and astigmatism within the available range;
Willing and able to complete all required postoperative visits;
Planned cataract removal by phacoemulsification;

Key exclusion criteria (23 listed)

Significant irregular corneal aberration as demonstrated by corneal topography;
Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism;
Any inflammation or edema (swelling) of the cornea;
Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.2 logMAR;
Reasonably expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy);

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 Toric IOL
AcrySof® ReSTOR® Multifocal IOL Model SA60D3Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient	Device	ReSTOR IOL

Primary outcome

Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5
Time frame: Month 12 from second eye implantation
Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. 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 first operative eye.
Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5
Time frame: Month 12 from second eye implantation
VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. 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 first operative eye.
Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5
Time frame: Month 12 from second eye implantation
The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.

1 secondary outcome

Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Time frame: Month 12 from second eye implantation

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 Toric IOL	386	373
ReSTOR IOL	188	182

Primary outcome: Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5

Time frame: Month 12 from second eye implantation. Least squares mean (Standard Error). Unit: logMAR

Measure	ReSTOR Toric IOL n = 373	ReSTOR IOL n = 180
Value	0.126 (0.013)	0.125 (0.015)

ReSTOR Toric IOL vs ReSTOR IOL: Mean Difference (Final Values): 0.001

Population analysed: This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.

Primary outcome: Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5

Time frame: Month 12 from second eye implantation. Mean (Standard Deviation). Unit: logMAR

Measure	ReSTOR Toric IOL n = 373	ReSTOR IOL n = 180
Value	0.19 (0.015)	0.24 (0.017)

ReSTOR Toric IOL vs ReSTOR IOL: Mean Difference (Final Values): -0.044

Population analysed: This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.

Primary outcome: Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5

Time frame: Month 12 from second eye implantation. Number. Unit: percentage of participants

Measure	ReSTOR Toric IOL n = 386	ReSTOR IOL n = 188
First Implanted Eye	1.04	2.13
Second Implanted Eye	0.52	2.13

Population analysed: This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). For participants with actual SSIs, performance testing outcomes conducted prior to the secondary intervention were carried forward to the final analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: This analysis group 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
ReSTOR Toric IOL	45 of 386 (11.7%)	48 of 386 (12.4%)	Not reported
ReSTOR IOL	21 of 188 (11.2%)	28 of 188 (14.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
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.

Expert Clinical Project Lead, GCRA, Surgical study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL and AcrySof® ReSTOR® Multifocal IOL Model SA60D3 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 12 inclusion and 23 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 Jun 2018. 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 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?

Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5 (time frame: Month 12 from second eye implantation). The study lists 3 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 NCT01424189, 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 29 Jun 2018.