Safety and Effectiveness of the Akreos Toric Intraocular Lens.

Cataract Clinical Trial

Official title:

Monocular Study to Evaluate the Safety and Effectiveness of the Akreos™ Toric IOL When Used to Correct Primary Aphakia With the Reduction of Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825513
• Other study ID #: 566
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2009
• Last updated: March 19, 2013
• Start date: February 2009
• Est. completion date: September 2012

Study information

• Verified date: March 2013
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• Akreos Toric IOL
Lens implant following cataract surgery
• Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
Lens implant following cataract surgery

Locations

Country	Name	City	State
Sweden	Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of cylinder, Lens axis misalignment as determined by a photographic method.		32 months	No
Secondary	Lens misalignment as determined by postoperative manifest refraction and vector analysis.		32 months	No