Back to resultsEvaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.
Primary Purpose
Cataract
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Akreos MI Five-O
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract extraction, Phacoemulsification
Eligibility 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.
Sites / Locations
- Augenzentrum Maus Wolfsstr 16
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Akreos MI Five-O
Arm Description
Accommodating intraocular lens
Outcomes
Primary Outcome Measures
Visual acuity
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
Best corrected near Visual acuity Intermediate visual acuity with distance best correction Subjective near point of accommodation (push down test)
Full Information
NCT ID
NCT00804726
First Posted
December 8, 2008
Last Updated
January 15, 2014
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00804726
Brief Title
Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.
Official Title
A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Test lens did not meet near visual efficacy endpoints
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract extraction, Phacoemulsification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Akreos MI Five-O
Arm Type
Experimental
Arm Description
Accommodating intraocular lens
Intervention Type
Device
Intervention Name(s)
Akreos MI Five-O
Intervention Description
Small incision cataract surgery with phacoemulsification cataract extraction and Akreos MI Five-O IOL surgical implantation
Primary Outcome Measure Information:
Title
Visual acuity
Description
Uncorrected distance visual acuity Best corrected distance visual acuity Uncorrected near visual acuity Uncorrected intermediate visual acuity Near visual acuity with distance best correction
Time Frame
5 visits up to 420 days
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Best corrected near Visual acuity Intermediate visual acuity with distance best correction Subjective near point of accommodation (push down test)
Time Frame
5 visits up to 420 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Allmeier, PhD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Augenzentrum Maus Wolfsstr 16
City
Koln
ZIP/Postal Code
50667
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.
We'll reach out to this number within 24 hrs