Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Binocular Visual Acuity at Distance, Near and Intermediate
Study Overview
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 AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
ReSTOR +3 Multifocal Lens
Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Intervention: AcrySof ReSTOR Aspheric IOL model SN6AD1 (Device)
Outcomes
Primary Outcomes
Binocular Visual Acuity at Distance, Near and Intermediate
Time Frame: 6 months after surgery
Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Secondary Outcomes
No secondary outcomes reported