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

This study has been terminated.

(Test lens did not meet near visual efficacy endpoints)

Sponsor:

Information provided by:

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00804726

First received: December 8, 2008

Last updated: June 17, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 8, 2008

Last Updated Date

June 17, 2011

Start Date ^ICMJE

November 2008

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual acuity [ Time Frame: 5 visits up to 420 days ] [ Designated as safety issue: No ]

Uncorrected distance visual acuity Best corrected distance visual acuity Uncorrected near visual acuity Uncorrected intermediate visual acuity Near visual acuity with distance best correction

Original Primary Outcome Measures ^ICMJE

Distance visual acuity. Near visual acuity. Intermediate visual acuity. Near visual acuity with distance best correction. Predictability of refractive outcomes. Incidence of adverse events. [ Time Frame: 420 days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00804726 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Visual acuity [ Time Frame: 5 visits up to 420 days ] [ Designated as safety issue: No ]

Best corrected near Visual acuity Intermediate visual acuity with distance best correction Subjective near point of accommodation (push down test)

Original Secondary Outcome Measures ^ICMJE

Best corrected near visual acuity. Intermediate visual acuity with distance best correction. Subjective near point of accommodation (push down test). [ Time Frame: 420 days ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cataract

Intervention ^ICMJE

Device: Akreos MI Five-O IOL

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

Study Arm (s)

Experimental: Akreos MI Five-O

Accommodating intraocular lens

Intervention: Device: Akreos MI Five-O IOL

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00804726

Other Study ID Numbers ^ICMJE

580

Has Data Monitoring Committee

Responsible Party

Anne Williart, MD, Bausch & Lomb Incorporated

Study Sponsor ^ICMJE

Bausch & Lomb Incorporated

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Helmut Allmeier, PhD

Bausch & Lomb Incorporated

Information Provided By

Bausch & Lomb Incorporated

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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