Phase 4
N=64
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01166971 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Defocus Curve — 0.585; 0.653; 0.490; 0.475 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ReSTOR +3 (Device); Tecnis MF (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Defocus Curve |
0.585; 0.653; 0.490; 0.475; 0.388; 0.337 | — |
Summary
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.
Eligibility Criteria
Inclusion Criteria
- diagnosed with bilateral cataracts
- candidate for presbyopic lens
Exclusion Criteria
- >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
- pre-existing conditions that could skew the results
Data sourced from ClinicalTrials.gov (NCT01166971). 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.