STAAR Visian Toric ICL Post-Approval Study

Study Overview
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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.

Official Title
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Post-Approval Study of the Visian Toric Implantable Collamer Lens

Conditions
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Myopic Astigmatism

Intervention / Treatment
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* Device: Visian TICL


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Visian TICL<br>STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism. | Device: Visian TICL<br>* 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.<br>* Other names: TMICL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 18 to 24 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Through study completion, an average of 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nearsightedness, phakic IOL, Toric ICL, TICL, TMICL, Visian, astigmatism