CataractNCT01257217
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
A study testing AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT and Acri.LISA® 366D IOL in people with Cataract, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery. 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 Model SN6AD1, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT and Acri.LISA® 366D IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent;
- Able to attend postoperative examinations per protocol schedule;
- Diagnosed with bilateral cataracts;
- Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
- Preoperative astigmatism ≤ 2.5 diopter;
- Good ocular health, with the exception of cataracts;
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- Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
- Able to undergo second eye surgery within one month of the first eye surgery;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Previous corneal surgery;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Any ocular disease and/or condition that may compromise study results;
- Pregnant or planning pregnancy during course of study;
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Diabetic retinopathy;
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- Macular degeneration;
- History of retinal detachment;
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs
The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.
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 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.
- Conditions
- Cataract
- Being tested
- AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, Acri.LISA® 366D IOL, Acri.LISA® 466TD Toric IOL
- Keywords
- Intraocular Lens, Presbyopia, multifocal
- Medical subject headings
- Cataract, Presbyopia
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 IOL Model SN6AD1Device
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TTDevice
Also called Models SND1T2, 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
Acri.LISA® 366D IOLDevice
Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient
Acri.LISA® 466TD Toric IOLDevice
Aspheric diffractive IOL with +3.75 D add power and astigmatism correction 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 Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation Receives: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT |
| Acri.LISA | Active comparator | Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation Receives: Device: Acri.LISA® 366D IOL; Device: Acri.LISA® 466TD Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Binocular Defocus VA at Month 3
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power 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 3 from second eye implantation
Secondary outcomes (5)
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Visual acuity (VA) was tested binocularly (both eyes together) 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 3 from second eye implantation
Uncorrected Visual Acuity Across a Range of Distances at Month 3
VA was tested binocularly 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 3 from second eye implantation
Mean Refractive Spherical Equivalent at Month 3
A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.
Measured: Month 3 from second eye implantation
Mean Radner Reading Speed
Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.
Measured: Month 3 from second eye implantation
Patient Reported Outcomes at Month 3
The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated 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 3 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.
- First posted9 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 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.
- 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
- 31 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
- NCT01257217
- Sponsor's protocol ID
- M09-051
- Status last verified
- Mar 2017
- First submitted
- 8 Dec 2010
- 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
- A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs
- ClinicalTrials.gov ID
- NCT01257217
- Acronym / sponsor ID
- M09-051
- Conditions
- Cataract
- Keywords
- Intraocular Lens, Presbyopia, multifocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Dec 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.
The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.
Detailed description
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReSTOR +3 | Experimental | Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TTAcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation |
| Acri.LISA | Active comparator | Device: Acri.LISA® 366D IOL, Device: Acri.LISA® 466TD Toric IOLAcri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign informed consent;
- Able to attend postoperative examinations per protocol schedule;
- Diagnosed with bilateral cataracts;
- Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
- Preoperative astigmatism ≤ 2.5 diopter;
Key exclusion criteria (9 listed)
- Previous corneal surgery;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Any ocular disease and/or condition that may compromise study results;
- Pregnant or planning pregnancy during course of study;
- 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 IOL Model SN6AD1Multifocal IOL implanted for long-term use over the lifetime of the cataract patient | Device | ReSTOR +3 |
| AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TTAlso: Models SND1T2, 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 +3 |
| Acri.LISA® 366D IOLAspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient | Device | Acri.LISA |
| Acri.LISA® 466TD Toric IOLAspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient | Device | Acri.LISA |
Primary outcome
Mean Binocular Defocus VA at Month 3
Time frame: Month 3 from second eye implantation
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power 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.
5 secondary outcomes
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Time frame: Month 3 from second eye implantation
Uncorrected Visual Acuity Across a Range of Distances at Month 3
Time frame: Month 3 from second eye implantation
Mean Refractive Spherical Equivalent at Month 3
Time frame: Month 3 from second eye implantation
Mean Radner Reading Speed
Time frame: Month 3 from second eye implantation
Patient Reported Outcomes at Month 3
Time frame: Month 3 from 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.
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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.
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 Model SN6AD1, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT and Acri.LISA® 366D 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 9 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?
Mean Binocular Defocus VA at Month 3 (time frame: Month 3 from second eye implantation). 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.