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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 29, 2014