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

Cataract Clinical Trial

Official title:

A Prospective, Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber Intraocular Lens (IOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394379
• Other study ID #: 858
• Status: Completed
• Start date: March 19, 2015
• Est. completion date: August 5, 2019

Study information

• Verified date: November 2019
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated	Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinically significant IOL vaulting	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.	Up to 3 years