Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens

Bausch + Lomb

Status and phase

Completed

Phase 4

Conditions

Cataract

Aphakia

Treatments

Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00838045

451

Details and patient eligibility

About

This study is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.

Enrollment

125 patients

Sex

All

Ages

50 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
Subjects must require a lens power from 15 to 30 diopters.
Subjects must have a visual potential of 20/40 or better in the study eye.

Exclusion criteria

Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
Subjects with any inflammation or edema (swelling) of the cornea.
Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
Subjects with previous retinal detachment.
Subjects with diabetic retinopathy (proliferative or non-proliferative).
Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
Subjects who have already received an Akreos TL IOL in the fellow eye.