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OpenTrials
Completed

NCT Number: NCT02394379

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trulign™ Toric IOL

Device

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

Primary outcomes

  1. Incidence of clinically significant IOL vaulting

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2015
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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