To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL
following cataract surgery.
The objective of this post approval safety study is to evaluate the incidence of IOL
vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery at up to
three years post implantation.
- Subjects who are able and willing to comply with the follow-up schedule
- Subjects must have a clinically documented diagnosis of age-related cataract that is
considered amenable to treatment with standard phacoemulsification/extracapsular
- Subjects must require a lens power from 4 to 33 D
- Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than
20/40, with or without a glare source
- Subjects with any anterior segment pathology in the study eye likely to increase the
risk of complications from phacoemulsification cataract surgery
- Subjects with associated ocular conditions which could affect the stability of the
- Subjects with clinically significant irregular corneal astigmatism in the study eye