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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00838045
First received: February 5, 2009
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Bast Corrected Visual Acuity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    best-corrected visual acuity (BCVA)


Secondary Outcome Measures:
  • Uncorrected Visual Acuity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Manifest Refraction [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00838045     History of Changes
Other Study ID Numbers: 451
Study First Received: February 5, 2009
Last Updated: December 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Aphakia
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013