STAAR Visian Toric ICL Post-Approval Study

NCT ID: NCT04516772

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2024-12-11

Brief Summary

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The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).

Detailed Description

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This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.

Conditions

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Myopic Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All enrolled subjects will undergo phakic eye surgery to have the STAAR Visian Toric Implantable Collamer Lens (TICL) implanted in one or both eligible eyes.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Visian TICL

STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.

Group Type OTHER

Visian TICL

Intervention Type DEVICE

The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.

Interventions

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Visian TICL

The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.

Intervention Type DEVICE

Other Intervention Names

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Visian Toric ICL TMICL

Eligibility Criteria

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Inclusion Criteria

* Moderate to high myopia with astigmatism correctable with available TICL powers.
* Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
* Able and willing to return for scheduled follow-up examinations after surgery.
* Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.

Exclusion Criteria

* Insulin-dependent diabetes or diabetic retinopathy.
* History of previous ocular surgery.
* Cataract of any grade.
* Monocular.
* Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Staar Surgical Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Egamino, PhD

Role: STUDY_DIRECTOR

VP, Clinical Affairs

Locations

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Aloha Laser Vision, LLC

Honolulu, Hawaii, United States

Site Status

Price Vision Group,

Indianapolis, Indiana, United States

Site Status

Solomon Eye Physicians and Surgeons/Bowie Vision Institute

Bowie, Maryland, United States

Site Status

Vance Thompson Vision

Omaha, Nebraska, United States

Site Status

Vance Thompson Vision

West Fargo, North Dakota, United States

Site Status

Cleveland Eye Clinic

Brecksville, Ohio, United States

Site Status

Key-Whitman Eye Center

Dallas, Texas, United States

Site Status

Hoopes Vision/Hoopes, Durrie, Rivera Research

Draper, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CP18-02

Identifier Type: -

Identifier Source: org_study_id

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