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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00838045
Collaborator
(none)
125
1
1
24
5.2

Study Details

Study Description

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
  • Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
125 participants
Allocation:
N/A
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 :
Sep 1, 2006
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Bast Corrected Visual Acuity [24 months]

    best-corrected visual acuity (BCVA)

Secondary Outcome Measures

  1. Uncorrected Visual Acuity [24 months]

  2. Manifest Refraction [24 Months]

    mean manifest refraction

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 79 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00838045
Other Study ID Numbers:
  • 451
First Posted:
Feb 6, 2009
Last Update Posted:
Dec 9, 2011
Last Verified:
Dec 1, 2011
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2011