Toric Intraocular Lens Following Cataract Surgery

Bausch + Lomb

Status

Completed

Conditions

Cataract

Astigmatism

Treatments

Device: Toric Accommodating Lens

Device: Accommodating Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01140477

650

Details and patient eligibility

About

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.

Enrollment

229 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.