Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.

A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00804726

Enrollment

Registered

2008-12-09

Start date

2008-11-30

Completion date

2010-07-31

Last updated

2014-01-17

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

Conditions

Cataract

Keywords

Cataract extraction, Phacoemulsification

Brief summary

The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.

Interventions

DEVICEAkreos MI Five-O

Small incision cataract surgery with phacoemulsification cataract extraction and Akreos MI Five-O IOL surgical implantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects must have a clinically documented diagnosis of age-related cataract. * Subjects must have clear intraocular media other than cataract. * Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.

Exclusion criteria

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. * Subjects with diagnosis of degenerative visual disorder. * Subjects who have any inflammation or edema (swelling) of the cornea. * Subjects with immunodeficiency disorders. * Subjects who have had previous intraocular surgery in the study eye. * Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture. * Subjects with chronic use of systemic steroids or immunosuppressive medications.

Design outcomes

Primary

Measure	Time frame	Description
Visual acuity	5 visits up to 420 days	Uncorrected distance visual acuity Best corrected distance visual acuity Uncorrected near visual acuity Uncorrected intermediate visual acuity Near visual acuity with distance best correction

Secondary

Measure	Time frame	Description
Visual acuity	5 visits up to 420 days	Best corrected near Visual acuity Intermediate visual acuity with distance best correction Subjective near point of accommodation (push down test)

Countries

Germany

Outcome results

None listed

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