Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens
1 other identifier
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedDecember 9, 2011
December 1, 2011
1.6 years
February 5, 2009
December 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Bast Corrected Visual Acuity
best-corrected visual acuity (BCVA)
24 months
Secondary Outcomes (2)
Uncorrected Visual Acuity
24 months
Manifest Refraction
24 Months
Study Arms (1)
Akreos TL intraocular lens
EXPERIMENTALBausch \& Lomb Akreos TL intraocular lens
Interventions
Surgery to implant the Bausch \& Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum der J.W. Goethe-Universität
Frankfurt, 60590, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Kohnen
Klinikum der J.W. Goethe-Universität
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2009
First Posted
February 6, 2009
Study Start
September 1, 2006
Primary Completion
April 1, 2008
Study Completion
September 1, 2008
Last Updated
December 9, 2011
Record last verified: 2011-12