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Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00838045
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : December 9, 2011
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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.

Condition or disease Intervention/treatment Phase
Cataract Aphakia Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens
Study Start Date : September 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Akreos TL intraocular lens
Bausch & Lomb Akreos TL intraocular lens
Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.

Primary Outcome Measures :
  1. Bast Corrected Visual Acuity [ Time Frame: 24 months ]
    best-corrected visual acuity (BCVA)

Secondary Outcome Measures :
  1. Uncorrected Visual Acuity [ Time Frame: 24 months ]
  2. Manifest Refraction [ Time Frame: 24 Months ]
    mean manifest refraction

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00838045

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Klinikum der J.W. Goethe-Universität
Frankfurt, Germany, 60590
Sponsors and Collaborators
Bausch & Lomb Incorporated
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Principal Investigator: Thomas Kohnen Klinikum der J.W. Goethe-Universität

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Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00838045     History of Changes
Other Study ID Numbers: 451
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases