Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
NCT ID: NCT01290068
Last Updated: 2018-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
208 participants
INTERVENTIONAL
2011-04-30
2012-10-31
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, bilateral implantation
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
ReSTOR +3 Toric
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
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
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 IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Monofocal
Monofocal IOL, bilateral implantation
Monofocal IOL
Monofocal IOL 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
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 IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Monofocal IOL
Monofocal IOL 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
* 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;
* 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.
Exclusion Criteria
* 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;
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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RDG-10-269
Identifier Type: -
Identifier Source: org_study_id
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