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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838045
First Posted: February 6, 2009
Last Update Posted: December 9, 2011
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.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
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 Intervention Phase
Cataract Aphakia Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

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


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


Enrollment: 125
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00838045


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00838045     History of Changes
Other Study ID Numbers: 451
First Submitted: February 5, 2009
First Posted: February 6, 2009
Last Update Posted: December 9, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Cataract
Aphakia
Lens Diseases
Eye Diseases