Safety and Effectiveness of the Akreos Toric Intraocular Lens.

Bausch + Lomb

Status and phase: Completed; Phase 4

Conditions: Cataract; Astigmatism

Treatments: Device: Akreos Toric IOL; Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00825513

566

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
• Subjects must require a lens power from 15 to 30 diopters.

Exclusion criteria

• Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
• Subjects with corneal pathology potentially affecting topography.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

Akreos Toric

Experimental group

Description:

Akreos Toric Intraocular Lens

Treatment:

Device: Akreos Toric IOL

Akreos Advanced

Active Comparator group

Description:

Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Treatment:

Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)