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

Not Applicable

Terminated

• Conditions: Cataract
• Interventions: Device: Akreos MI Five-O

• Registration Number: NCT00804726
• Lead Sponsor: Bausch & Lomb Incorporated

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 available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2010-05
• Study Completion: 2010-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Akreos MI Five-O	Akreos MI Five-O	Accommodating intraocular lens

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Augenzentrum Maus Wolfsstr 16; 🇩🇪 Koln, Germany