CompletedInterventionalNot ApplicableUpdated Dec 5, 2023
Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model... | NCT00759668 | Trialant
CompletedInterventionalNot ApplicableUpdated Jan 26, 2011
Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
ClinicalTrials.gov ID
NCT00759668
Lead Sponsor
Alcon ResearchINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
35Actual
Last Update Posted
Jan 26, 2011Estimated
Start Date
May 2007
Primary Completion Date
Sep 2009Actual
Completion Date
Sep 2009Actual
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 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
Cataract
Acrysof Natural ReSTOR SN60D3
Acrysof Natural Monofocal SN60AT
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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