CataractNCT01200511

Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

A study testing AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL 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 is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Cataract
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: 49 participants
Where: No sites listed yet
Study dates: Aug 2010to Sep 2011
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign informed consent;
Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
Able to undergo second eye surgery within one month (30 days) of first eye surgery;
Able to attend postoperative examinations per protocol schedule;
Qualify for a AcrySof IQ Toric IOL in both eyes;
Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;

Show all 9Show fewer

Residual refractive cylinder of ≤0.5 D in both eyes;
Good ocular health;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
Amblyopia;
Previous corneal surgery;
Clinically significant corneal endothelial dystrophy;
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
History of retinal detachment;
Pregnant or planning to become pregnant during course of study;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL

Read the detailed description

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Conditions: Cataract
Being tested: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Keywords: intraocular lens, multifocal, toric
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
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 NCT01200511
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.

Uncorrected Visual Acuity Across a Range of Distances at Month 6
Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Measured: Month 6 from second eye implantation
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Measured: Month 6 from second eye implantation
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.
Measured: Month 6 from second eye implantation

Secondary outcomes (1)

Patient Reported Outcomes at Month 6
The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.
Measured: Month 6 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.

Aug 2010Sep 2011

First posted13 Sep 2010 (estimated)
Study startAug 2010
Primary completionSep 2011
Study completionSep 2011

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.
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: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01200511
Sponsor's protocol ID: M09-052
Status last verified: Mar 2017
First submitted: 10 Sep 2010
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?

Official record

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy

All Cataract 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: A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL
ClinicalTrials.gov ID: NCT01200511
Acronym / sponsor ID: M09-052
Conditions: Cataract
Keywords: intraocular lens, multifocal, toric
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 13 Sep 2010 (estimated)
Results: Posted 20 Apr 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: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Sign informed consent;
Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
Able to undergo second eye surgery within one month (30 days) of first eye surgery;
Able to attend postoperative examinations per protocol schedule;
Qualify for a AcrySof IQ Toric IOL in both eyes;

Key exclusion criteria (8 listed)

Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
Amblyopia;
Previous corneal surgery;
Clinically significant corneal endothelial dystrophy;
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);

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, SND1T5Multifocal 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

Uncorrected Visual Acuity Across a Range of Distances at Month 6
Time frame: Month 6 from second eye implantation
Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
Time frame: Month 6 from second eye implantation
VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
Time frame: Month 6 from second eye implantation
Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.

1 secondary outcome

Patient Reported Outcomes at Month 6
Time frame: Month 6 from second eye implantation

Results and safety

Results posted to the registry on 20 Apr 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 Toric	49	44

Primary outcome: Uncorrected Visual Acuity Across a Range of Distances at Month 6

Time frame: Month 6 from second eye implantation. Mean (Standard Deviation). Unit: logMAR

Measure	ReSTOR +3.0 Toric n = 42
Far distance 4 meters (m)	0.05 (0.10)
Intermediate 70 centimeters (cm)	0.15 (0.13)
Intermediate 60 cm	0.09 (0.11)
Intermediate 50 cm	0.05 (0.09)
Near 40 cm	0.07 (0.09)
Near - preferred	0.04 (0.08)

Population analysed: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

Primary outcome: Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6

Time frame: Month 6 from second eye implantation. Mean (Standard Deviation). Unit: logMAR

Measure	ReSTOR +3.0 Toric n = 42
Far distance 4 m	0.00 (0.06)
Intermediate 70 cm	0.19 (0.14)
Intermediate 60 cm	0.14 (0.14)
Intermediate 50 cm	0.06 (0.10)
Near 40 cm	0.04 (0.07)
Near - preferred distance	0.05 (0.08)

Population analysed: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

Primary outcome: Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6

Time frame: Month 6 from second eye implantation. Number. Unit: percentage of participants

Measure	ReSTOR +3.0 Toric n = 44
± 0.5D	84.5
± 0.75D	92.9
±1.0D	95.2

Population analysed: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ReSTOR +3.0 Toric	7 of 49 (14.3%)	3 of 49 (6.1%)	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 Cataract

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy

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.

Brand Lead, Surgical, Global Medical Affairs 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 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 9 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 2 Jul 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 20 Apr 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?

Uncorrected Visual Acuity Across a Range of Distances at Month 6 (time frame: Month 6 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 NCT01200511.

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; AzTrials last refreshed its copy on 29 Oct 2026.