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

NCT ID: NCT00804726

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-07-31

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.

Conditions

Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Akreos MI Five-O

Accommodating intraocular lens

Group Type: EXPERIMENTAL

Akreos MI Five-O

Intervention Type: DEVICE

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

Interventions

Akreos MI Five-O

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helmut Allmeier, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Augenzentrum Maus Wolfsstr 16

Cologne, , Germany

Countries

Germany

Other Identifiers

580

Identifier Type: -

Identifier Source: org_study_id