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

Cataract Clinical Trial

Official title:

A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838045
• Other study ID #: 451
• Status: Completed
• Phase: Phase 4
• First received: February 5, 2009
• Last updated: December 7, 2011
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinikum der J.W. Goethe-Universität	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bast Corrected Visual Acuity	best-corrected visual acuity (BCVA)	24 months	No
Secondary	Uncorrected Visual Acuity		24 months	No
Secondary	Manifest Refraction	mean manifest refraction	24 Months	No