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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00804726
• Other study ID #: 580
• Status: Terminated
• Phase: N/A
• First received: December 8, 2008
• Last updated: January 15, 2014
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: January 2014
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
Germany	Augenzentrum Maus Wolfsstr 16	Koln

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Uncorrected distance visual acuity Best corrected distance visual acuity Uncorrected near visual acuity Uncorrected intermediate visual acuity Near visual acuity with distance best correction	5 visits up to 420 days	No
Secondary	Visual acuity	Best corrected near Visual acuity Intermediate visual acuity with distance best correction Subjective near point of accommodation (push down test)	5 visits up to 420 days	No