N/A
N=64
ReSTOR Natural +3.0D Study In Japan
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00758576 ↗Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Dec 2010
Primary outcome: Primary: Uncorrected Intermediate Visual Acuity — 0.771; 0.861 Decimal Visual Acuity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uncorrected Intermediate Visual Acuity |
0.771; 0.861 | — |
| PRIMARY Uncorrected Distance Visual Acuity |
1.122 | — |
| PRIMARY Uncorrected Near Visual Acuity |
1.082 | — |
Summary
The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.
Eligibility Criteria
Inclusion Criteria
- Planned bilateral cataract removal by phacoemulsification
- Potential postoperative best corrected visual acuity of 0.5 or over
- 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry
Exclusion Criteria
- Poorly controlled glaucoma
- Progressive diabetic retinopathy
Data sourced from ClinicalTrials.gov (NCT00758576). 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.