Phase 4
N=34
Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00710931 ↗Enrolled (actual)
34
Serious AEs
—
Results posted
Nov 2011
Primary outcome: Primary: Binocular Visual Acuity at Distance, Near and Intermediate — 0.00; 0.13; 0.07; 0.00 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- AcrySof ReSTOR Aspheric IOL model SN6AD1 (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Visual Acuity at Distance, Near and Intermediate |
0.00; 0.13; 0.07; 0.00; 0.09; 0.07 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00710931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.