Status:
COMPLETED
Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
The purpose of the study is: * to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective s...
Eligibility Criteria
Inclusion
- Inclusion:
- Written informed consent
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00759668
Start Date
May 1 2007
End Date
September 1 2009
Last Update
January 26 2011
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134