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

Bausch & Lomb Incorporated1 site in 1 country10 target enrollmentNovember 2008

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Bausch & Lomb Incorporated
Enrollment: 10
Locations: 1
Primary Endpoint: Visual acuity
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

July 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Visual acuity

Time Frame: 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