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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014