Back to resultsEvaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
Primary Purpose
Cataract, Aphakia
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
- Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
- Subjects must require a lens power from 15 to 30 diopters.
- Subjects must have a visual potential of 20/40 or better in the study eye.
Exclusion Criteria:
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with any inflammation or edema (swelling) of the cornea.
- Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
- Subjects with previous retinal detachment.
- Subjects with diabetic retinopathy (proliferative or non-proliferative).
- Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
- Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
- Subjects who have already received an Akreos TL IOL in the fellow eye.
Sites / Locations
- Klinikum der J.W. Goethe-Universität
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Akreos TL intraocular lens
Arm Description
Bausch & Lomb Akreos TL intraocular lens
Outcomes
Primary Outcome Measures
Bast Corrected Visual Acuity
best-corrected visual acuity (BCVA)
Secondary Outcome Measures
Uncorrected Visual Acuity
Manifest Refraction
mean manifest refraction
Full Information
NCT ID
NCT00838045
First Posted
February 5, 2009
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00838045
Brief Title
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
Official Title
A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
September 2008 (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
This study is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Aphakia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Akreos TL intraocular lens
Arm Type
Experimental
Arm Description
Bausch & Lomb Akreos TL intraocular lens
Intervention Type
Device
Intervention Name(s)
The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Intervention Description
Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.
Primary Outcome Measure Information:
Title
Bast Corrected Visual Acuity
Description
best-corrected visual acuity (BCVA)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Uncorrected Visual Acuity
Time Frame
24 months
Title
Manifest Refraction
Description
mean manifest refraction
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
Subjects must require a lens power from 15 to 30 diopters.
Subjects must have a visual potential of 20/40 or better in the study eye.
Exclusion Criteria:
Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
Subjects with any inflammation or edema (swelling) of the cornea.
Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
Subjects with previous retinal detachment.
Subjects with diabetic retinopathy (proliferative or non-proliferative).
Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
Subjects who have already received an Akreos TL IOL in the fellow eye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kohnen
Organizational Affiliation
Klinikum der J.W. Goethe-Universität
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum der J.W. Goethe-Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
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