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OpenTrials
Completed

NCT Number: NCT00825513

Safety and Effectiveness of the Akreos Toric Intraocular Lens.

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

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Key information

Conditions

Cataract Astigmatism Eye Diseases Lens Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital

Umeå, SE-901 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Akreos Toric IOL

Device

Lens implant following cataract surgery

Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Device

Lens implant following cataract surgery

Primary outcomes

  1. Reduction of cylinder, Lens axis misalignment as determined by a photographic method.

    Time frame: 32 months

Secondary outcomes

  1. Lens misalignment as determined by postoperative manifest refraction and vector analysis.

    Time frame: 32 months

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 21, 2009
Registry last updated
Mar 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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