Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
NCT ID: NCT00759668
Last Updated: 2011-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2007-05-31
2009-09-30
Brief Summary
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* to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
* to assess patient satisfaction before and after implant
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SN60D3
AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3
Acrysof Natural ReSTOR SN60D3
Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.
SN60AT
AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT
Acrysof Natural Monofocal SN60AT
Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.
Interventions
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Acrysof Natural ReSTOR SN60D3
Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.
Acrysof Natural Monofocal SN60AT
Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.
Eligibility Criteria
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Inclusion Criteria
* Age: ≥ 50 years ≤ 75 years
* Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
* Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
* Potential post operative Visual Acuity (VA) ≥ 20/40
* Second eye surgery to take place no longer than 45 days after the first implant
Exclusion:
* Irregular optical aberrations;
* Pupil diameter in scotopic conditions more than 6 mm
* Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
* Other exclusions as from ReSTOR Directions for Use (DFU)
50 Years
75 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Alcon
Locations
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Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Countries
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Other Identifiers
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IT 06 01
Identifier Type: -
Identifier Source: org_study_id
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