Status:
COMPLETED
Toric Intraocular Lens Following Cataract Surgery
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract
Astigmatism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT01140477
Start Date
June 1 2010
End Date
October 1 2012
Last Update
September 8 2014
Active Locations (1)
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1
B&L Surgical
Bridgewater, New Jersey, United States, 08807