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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804726
Recruitment Status : Terminated (Test lens did not meet near visual efficacy endpoints)
First Posted : December 9, 2008
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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.

Condition or disease Intervention/treatment
Cataract Device: Akreos MI Five-O

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2008
Primary Completion Date : May 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 5 visits up to 420 days ]
    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 :
  1. Visual acuity [ Time Frame: 5 visits up to 420 days ]
    Best corrected near Visual acuity Intermediate visual acuity with distance best correction Subjective near point of accommodation (push down test)

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00804726

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

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00804726     History of Changes
Other Study ID Numbers: 580
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Bausch & Lomb Incorporated:
Cataract extraction

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases