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

A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00838045

Enrollment

125

Registered

2009-02-06

Start date

2006-09-30

Completion date

2008-09-30

Last updated

2011-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphakia, Cataract

Brief summary

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.

Interventions

DEVICEThe Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL

Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 79 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Bast Corrected Visual Acuity	24 months	best-corrected visual acuity (BCVA)

Secondary

Measure	Time frame	Description
Uncorrected Visual Acuity	24 months	—
Manifest Refraction	24 Months	mean manifest refraction

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026