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

Phase 4

Completed

• Conditions: Cataract; Aphakia
• Interventions: Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL

• Registration Number: NCT00838045
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-04
• Study Completion: 2008-09
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Akreos TL intraocular lens	The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL	Bausch \& Lomb Akreos TL intraocular lens

Primary Outcome Measures

Name	Time	Method
Bast Corrected Visual Acuity	24 months	best-corrected visual acuity (BCVA)

Secondary Outcome Measures

Name	Time	Method
Uncorrected Visual Acuity	24 months
Manifest Refraction	24 Months	mean manifest refraction

Trial Locations

Locations (1)

Klinikum der J.W. Goethe-Universität; 🇩🇪 Frankfurt, Germany