Toric Intraocular Lens Following Cataract Surgery

Completed · Not applicable

Conditions studied: Cataract, Astigmatism

In brief

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.

Key facts

Study ID

NCT01140477

Run by

Bausch & Lomb Incorporated

People needed

229

Starts

2010-06-01

Expected to finish

2012-10-01

Last updated by the study team

2014-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• B&L Surgical — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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