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

December 8, 2008
January 15, 2014
November 2008
May 2010   (final data collection date for primary outcome measure)
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
Distance visual acuity. Near visual acuity. Intermediate visual acuity. Near visual acuity with distance best correction. Predictability of refractive outcomes. Incidence of adverse events. [ Time Frame: 420 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00804726 on ClinicalTrials.gov Archive Site
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)
Best corrected near visual acuity. Intermediate visual acuity with distance best correction. Subjective near point of accommodation (push down test). [ Time Frame: 420 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.
A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cataract
Device: Akreos MI Five-O
Small incision cataract surgery with phacoemulsification cataract extraction and Akreos MI Five-O IOL surgical implantation
Experimental: Akreos MI Five-O
Accommodating intraocular lens
Intervention: Device: Akreos MI Five-O
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
July 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00804726
580
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Helmut Allmeier, PhD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP