N/A
N=229
Toric Intraocular Lens Following Cataract Surgery
Cataract · Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT01140477 ↗Enrolled (actual)
229
Serious AEs
9.6%
Results posted
Aug 2014
Primary outcome: Primary: Percent Reduction in Absolute Cylinder — 84.975; 46.498 percentage of intended cylinder reduct
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Toric Accommodating Lens (Device); Accommodating Lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Reduction in Absolute Cylinder |
84.975; 46.498 | — |
| SECONDARY Lens Misalignment |
4.660 | — |
| SECONDARY Visual Acuity |
0.004; 0.012 | — |
Summary
The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.
Eligibility Criteria
Inclusion Criteria
- Subjects must have a clinically documented diagnosis of age-related cataract
- Subjects must require a lens power from 16 to 27 diopters
- Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator
Exclusion Criteria
- Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated.
- Subjects with diagnoses of degenerative visual disorders.
- Subjects with conditions associated with increased risk of zonular rupture.
- Subjects who have had previous corneal surgery in the planned operative eye.
- Subjects with irregular corneal astigmatism.
- Subjects with clinically significant retinal pigment or epithelium/macular changes.
- Subjects with chronic use of systemic steroids or immunosuppressive medications.
- Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study.
- Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.
Data sourced from ClinicalTrials.gov (NCT01140477). 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.