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

Completed

• Conditions: Cataract
• Interventions: Device: Trulign™ Toric IOL

• Registration Number: NCT02394379
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Study Timeline

• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-16
• Study Start: 2015-03-19
• Study First Posted: 2015-03-20
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States