Post Approval Study to Evaluate the Trulign™ Toric Poster... | NCT02394379

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

NCT02394379

Sponsor

Bausch & Lomb Incorporated

Status

Completed

Last Update Posted

Nov 13, 2019Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Cataract

Interventions

Trulign™ Toric IOL

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2015Actual

Primary Completion Date

Aug 5, 2019Actual

Completion Date

Aug 5, 2019Actual

First Submitted Date

Mar 9, 2015

First Submission Date that Met QC Criteria

Mar 16, 2015

First Posted Date

Mar 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2019

Last Update Posted Date

Nov 13, 2019Actual

Name	Class
Bausch Health Americas, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trulign™ Toric IOL		Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens	Device: Trulign™ Toric IOL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trulign™ Toric IOL	Device	Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens	Trulign™ Toric IOL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects will be chosen from 30-50 clinical sites in the US. All subjects who meet Eligibility Criteria (below) will be consecutively offered enrollment until the site meets the maximum number of enrollees.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anya Loncaric	Valeant Pharmaceuticals NA / Bausch & Lomb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bausch & Lomb Incorporated		Rochester	New York	14609	United States

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases