Phase 4
N=60
Visual Function After Bilateral Implantation of AcrySof® Toric
Visual Function
Bottom Line
View on ClinicalTrials.gov: NCT00758550 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Uncorrected Visual Acuity (UCVA) — 0.06; 0.14 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- AcrySof® Toric IOL (Device); AcrySof Natural (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uncorrected Visual Acuity (UCVA) |
0.06; 0.14 | — |
| SECONDARY Questionnaire Results |
5.6; 4.5 | — |
Summary
The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.
Eligibility Criteria
Inclusion Criteria
- Bilateral cataracts
- 40~80 years of age
- 4 Days - 1 Week interval between a single patient's surgery
- dilated pupil size (in dim light) ≥ 4.0 mm
- Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters
- 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings
Exclusion Criteria
- Preoperative ocular pathology
- Previous intraocular or corneal surgery
- An increased risk for complications which could require vitreoretinal surgery
- Corneal irregularities
- Corneal opacities
- Current contact lens usage(within 6 months prior to first surgery)
Data sourced from ClinicalTrials.gov (NCT00758550). 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.