Status:
COMPLETED
Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]
Lead Sponsor:
Alcon Research
Conditions:
Cataracts
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.
Detailed Description
Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL M...
Eligibility Criteria
Inclusion
- Diagnosis of bilateral cataracts
- Willing and able to complete all required postoperative visits
- Calculated lens power within the available supply range
- Planned cataract removal by phacoemulsification
- Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
- Preoperative astigmatism less than 1.0 diopter
- Clear intraocular media other than cataract in study eyes
- Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
- Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
- Other protocol-defined inclusion criteria may apply
Exclusion
- Previous refractive surgery
- Inflammation or edema of the cornea
- Optic nerve atrophy
- Pregnancy
- Current participation in another investigational drug or device study
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT01510717
Start Date
February 1 2012
End Date
December 1 2012
Last Update
May 27 2015
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