Safety and Effectiveness of the Akreos Toric Intraocular Lens.

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00825513

Enrollment

198

Registered

2009-01-21

Start date

2009-02-28

Completion date

2012-09-30

Last updated

2013-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Cataract

Brief summary

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

Interventions

DEVICEAkreos Toric IOL

Lens implant following cataract surgery

DEVICEAkreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Lens implant following cataract surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Lens misalignment as determined by postoperative manifest refraction and vector analysis.	32 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026