Cataract
Conditions
Brief summary
To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery.
Detailed description
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.
Interventions
DEVICETrulign™ Toric IOL
Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens
Sponsors
Bausch Health Americas, Inc.
Bausch & Lomb Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 cataract extraction * 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
Exclusion criteria
* 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 IOL * Subjects with clinically significant irregular corneal astigmatism in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically significant IOL vaulting | Up to 3 years | IOL vaulting is position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting. The proportion of study eyes experiencing vaulting will be estimated by Kaplan-Meier method. |
Countries
United States
Outcome results
None listed