A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
NCT ID: NCT01257217
Last Updated: 2018-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2010-11-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ReSTOR +3
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
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Acri.LISA
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Acri.LISA® 366D IOL
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 IOL
Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Interventions
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AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
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 IOL
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 IOL
Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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;
* 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;
Exclusion Criteria
* 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;
* Macular degeneration;
* History of retinal detachment;
21 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Brand Lead, Surgical, Global Medical Affairs
Role: STUDY_DIRECTOR
Alcon Research
Other Identifiers
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M09-051
Identifier Type: -
Identifier Source: org_study_id
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