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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Terminated
CT.gov ID
NCT00804726
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
19.9
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Akreos MI Five-O
 N/A

Study Design

Study Type:
Interventional
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 :
Nov 1, 2008
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Visual acuity [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Augenzentrum Maus Wolfsstr 16 Koln Germany 50667

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Helmut Allmeier, PhD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00804726
Other Study ID Numbers:
  • 580
First Posted:
Dec 9, 2008
Last Update Posted:
Jan 17, 2014
Last Verified:
Jan 1, 2014
Keywords provided by Bausch & Lomb Incorporated
Cataract extraction
Phacoemulsification
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jan 17, 2014