CataractNCT01290068
Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
A study testing AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL and Monofocal IOL in people with Cataract, run by Alcon Research.
Trial summary
The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL and Monofocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 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 as per protocol schedule;
- Diagnosis of bilateral, age-related cataracts;
- Planned cataract removal via phacoemulsification with implantation of an IOL;
- Available to undergo second eye surgery within 6 weeks of the first eye surgery;
- Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
Show all 10Show fewer
- No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
- Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
- Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Previous corneal surgery and/or reshaping;
- Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
- Pregnant, lactating, or planning pregnancy during the course of study;
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation
The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
Read the detailed description
This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.
- Conditions
- Cataract
- Being tested
- AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, Monofocal IOL
- Keywords
- 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 IOLDevice
Also called SN6AD1
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 Toric IOLDevice
Also called SND1T2, 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
Monofocal IOLDevice
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
| Study group | Role | What they receive |
|---|---|---|
| ReSTOR +3 | Experimental | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation Receives: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL |
| ReSTOR +3 Toric | Experimental | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye Receives: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL |
| Monofocal | Active comparator | Monofocal IOL, bilateral implantation Receives: Device: Monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Classified as Responders
Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.
Measured: Month 6 after second eye implantation
Proportion of Participants Reporting Spectacle Independence at All Distances
Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.
Measured: Month 6 after second eye implantation
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)
Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.
Measured: Month 6 after second eye implantation
Secondary outcomes (1)
Median Total Spectacle Cost Prior to Any Reimbursement
Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.
Measured: Month 6 after second eye implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionOct 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.
- 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
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brand Lead, Surgical, Global Medical Affairs, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290068
- Sponsor's protocol ID
- RDG-10-269
- Status last verified
- Mar 2017
- First submitted
- 3 Feb 2011
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation
- ClinicalTrials.gov ID
- NCT01290068
- Acronym / sponsor ID
- RDG-10-269
- Conditions
- Cataract
- Keywords
- Intraocular Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Feb 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 assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
Detailed description
This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ReSTOR +3 | Experimental | Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOLAcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation |
| ReSTOR +3 Toric | Experimental | Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOLAcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye |
| Monofocal | Active comparator | Device: Monofocal IOLMonofocal IOL, 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)
- Willing and able to understand and sign an Informed Consent;
- Willing and able to attend post-operative examinations as per protocol schedule;
- Diagnosis of bilateral, age-related cataracts;
- Planned cataract removal via phacoemulsification with implantation of an IOL;
- Available to undergo second eye surgery within 6 weeks of the first eye surgery;
Key exclusion criteria (6 listed)
- Previous corneal surgery and/or reshaping;
- Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
- Pregnant, lactating, or planning pregnancy during the course of 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® +3.0 D Multifocal IOLAlso: SN6AD1Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient | Device | ReSTOR +3, ReSTOR +3 Toric |
| AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOLAlso: SND1T2, 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 Toric |
| Monofocal IOLMonofocal IOL implanted for long-term use over the lifetime of the cataract patient | Device | Monofocal |
Primary outcome
Percentage of Participants Classified as Responders
Time frame: Month 6 after second eye implantation
Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.
Proportion of Participants Reporting Spectacle Independence at All Distances
Time frame: Month 6 after second eye implantation
Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)
Time frame: Month 6 after second eye implantation
Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.
1 secondary outcome
Median Total Spectacle Cost Prior to Any Reimbursement
Time frame: Month 6 after second eye implantation
Results and safety
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
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
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 IOL, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL and Monofocal 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 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 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 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?
Percentage of Participants Classified as Responders (time frame: Month 6 after 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?
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.