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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

February 5, 2009
December 7, 2011
September 2006
April 2008   (final data collection date for primary outcome measure)
Bast Corrected Visual Acuity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
best-corrected visual acuity (BCVA)
Safety and effectiveness of the Bausch & Lomb Akreos TL intraocular lens. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00838045 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cataract
  • Aphakia
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.
Experimental: Akreos TL intraocular lens
Bausch & Lomb Akreos TL intraocular lens
Intervention: Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
September 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
50 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00838045
451
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Principal Investigator: Thomas Kohnen Klinikum der J.W. Goethe-Universität
Bausch & Lomb Incorporated
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP