## Protocol Section
### Identification Module
**NCT ID:** NCT02394379

**Brief Title:** Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber IOL

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

#### Organization Study ID Info
**ID:** 858
#### Organization
**Class:** INDUSTRY
**Full Name:** Bausch & Lomb Incorporated
### Status Module
#### Completion Date
**Date:** 2019-08-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-11-13

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-08-05

**Type:** ACTUAL

#### Start Date
**Date:** 2015-03-19

**Type:** ACTUAL

**Status Verified Date:** 2019-11

#### Study First Post Date
**Date:** 2015-03-20
**Type:** ESTIMATED
**Study First Submit Date:** 2015-03-09
**Study First Submit QC Date:** 2015-03-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Bausch Health Americas, Inc.

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bausch & Lomb Incorporated

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Cataract

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Trulign™ Toric IOL

**Label:** Trulign™ Toric IOL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Trulign™ Toric IOL

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

**Name:** Trulign™ Toric IOL

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Incidence of clinically significant IOL vaulting

**Time Frame:** Up to 3 years

### 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

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rochester

**Country:** United States

**Facility:** Bausch & Lomb Incorporated

**State:** New York

**Zip:** 14609

#### Overall Officials

**Official 1:**

**Affiliation:** Valeant Pharmaceuticals NA / Bausch & Lomb

**Name:** Anya Loncaric

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007905

- Term: Lens Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5638

- Name: Cataract

- Relevance: HIGH

- As Found: Cataract

- ID: M10917

- Name: Lens Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002386

- Term: Cataract

### Misc Info Module

- Version Holder: 2024-05-24
