Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber IOL

Bausch + Lomb

Status: Completed

Conditions: Cataract

Treatments: Device: Trulign™ Toric IOL

Study type: Observational

Funder types: Industry

Identifiers

NCT02394379

858

Details and patient eligibility

About

To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Trulign™ Toric IOL

Description:

Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens

Treatment:

Device: Trulign™ Toric IOL