Safety and Effectiveness of the Akreos Toric Intraocular Lens.

Phase 4

Completed

• Conditions: Cataract; Astigmatism
• Interventions: Device: Akreos Toric IOL; Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

• Registration Number: NCT00825513
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-21
• Study Start: 2009-02
• Primary Completion: 2012-03
• Study Completion: 2012-09
• Status Verified: 2013-03
• Disposition First Submitted: 2013-03-19
• Disposition First Submitted QC: 2013-03-19
• Last Update Submitted: 2013-03-19
• Disposition First Posted: 2013-03-25
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
• Subjects must require a lens power from 15 to 30 diopters.

Exclusion Criteria

• Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
• Subjects with corneal pathology potentially affecting topography.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Akreos Toric	Akreos Toric IOL	Akreos Toric Intraocular Lens
Akreos Advanced	Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)	Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Primary Outcome Measures

Name	Time	Method
Reduction of cylinder, Lens axis misalignment as determined by a photographic method.	32 months

Secondary Outcome Measures

Name	Time	Method
Lens misalignment as determined by postoperative manifest refraction and vector analysis.	32 months

Trial Locations

Locations (1)

Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital; 🇸🇪 Umea, Sweden