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.

Study Overview

• Status: Completed
• Conditions: Cataract; Aphakia
• Intervention / Treatment: Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany, 60590
    • Klinikum der J.W. Goethe-Universitat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bast Corrected Visual Acuity	best-corrected visual acuity (BCVA)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Visual Acuity		24 months
Manifest Refraction	mean manifest refraction	24 Months

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Thomas Kohnen, Klinikum der J.W. Goethe-Universitat

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (Estimate): February 6, 2009

Study Record Updates

• Last Update Posted (Estimate): December 9, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Aphakia
• Other Study ID Numbers: 451