Clinical Evaluation of a New Aspheric Intraocular Lens.

Bausch + Lomb

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: Advanced Akreos Adapt in one operated eye.; Device: Akreos Adapt in fellow operated eye.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00786565

001/04

Details and patient eligibility

About

This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.

Enrollment: 75 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery.
• Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.

Exclusion criteria

• Patients with corneal damage.
• Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
• Patients with any ocular pathology, other than the cataract, having repercussions on visual function:

Trial design

75 participants in 2 patient groups

Advanced Akreos Adapt

Experimental group

Description:

Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).

Treatment:

Device: Advanced Akreos Adapt in one operated eye.

Akreos Adapt

Experimental group

Description:

Akreos Adapt Spherical Intraocular Lens (IOL).

Treatment:

Device: Akreos Adapt in fellow operated eye.