Status:
COMPLETED
Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the...
Eligibility Criteria
Inclusion
- Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.
Exclusion
- Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
- All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00710931
Start Date
October 1 2008
End Date
September 1 2010
Last Update
December 12 2011
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134