Phase 4
N=34
Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL
Cataracts
Bottom Line
View on ClinicalTrials.gov: NCT00818116 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Uncorrected and Best Corrected Visual Acuities (Near and Distance) — 0.02; 0.01; 0.00; -0.03 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- AcrySof ReSTOR Aspheric IOL (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uncorrected and Best Corrected Visual Acuities (Near and Distance) |
0.02; 0.01; 0.00; -0.03 | — |
Summary
The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).
Eligibility Criteria
Inclusion Criteria
- Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
- 50~75 years of age
- <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.
Exclusion Criteria
- Patients with pre-existing conditions that could skew the results.
- Any of conditions before and during surgery specified in the product information.
Data sourced from ClinicalTrials.gov (NCT00818116). 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.