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 (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00804726
First received: December 8, 2008
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Cataract
Device: Akreos MI Five-O

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 10
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Akreos MI Five-O
Accommodating intraocular lens
Device: Akreos MI Five-O
Small incision cataract surgery with phacoemulsification cataract extraction and Akreos MI Five-O IOL surgical implantation

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804726

Locations
Germany
Augenzentrum Maus Wolfsstr 16
Koln, Germany, 50667
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Helmut Allmeier, PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00804726     History of Changes
Other Study ID Numbers: 580
Study First Received: December 8, 2008
Last Updated: January 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bausch & Lomb Incorporated:
Cataract extraction
Phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014