STAAR Visian Toric ICL Post-Approval Study

Staar Surgical Company125 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Myopic Astigmatism

Interventions

Visian TICLDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 Years

Medical Language ↔ Plain English

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. * Other protocol-specified inclusion criteria may apply. 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. * Other protocol-specified exclusion criteria may apply.

Locations (8)

Aloha Laser Vision, LLC

Honolulu, Hawaii, United States

Price Vision Group,

Indianapolis, Indiana, United States

Solomon Eye Physicians and Surgeons/Bowie Vision Institute

Bowie, Maryland, United States

Vance Thompson Vision

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Change in axis orientation of the TICL

Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative

Time frame: 18 to 24 months postoperative

Secondary Outcomes

Absolute Rotation of the TICL in treated eyes

* Absolute rotation of the TICL between visits * Absolute rotation of the TICL \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from intended orientation * Absolute rotation of the TICL at each visit

Time frame: 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery

Manifest refraction spherical equivalence (MRSE) and cylinder

MRSE and cylinder in treated eyes

Time frame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery

Ocular (adverse events) AEs

Incidence of AEs in treated eyes

Time frame: Through study completion, an average of 24 months

Data from ClinicalTrials.gov

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