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

NCT00804726 | Terminated

• 1 other identifier: 580
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Cataract extraction; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Visual acuity

  5 visits up to 420 days

Study Arms (1)

Akreos MI Five-O

EXPERIMENTAL

Accommodating intraocular lens

Device: Akreos MI Five-O

Interventions

Akreos MI Five-O DEVICE

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

Akreos MI Five-O

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Augenzentrum Maus Wolfsstr 16

Cologne, 50667, Germany

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Helmut Allmeier, PhD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

DE (1)