Post-Market Evaluation of the EVO ICL

Study Overview
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Brief Summary
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The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).

Detailed Description
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This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.

Official Title
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Post-Market Evaluation of the EVO ICL

Conditions
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Myopia, Myopic Astigmatism

Intervention / Treatment
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* Device: EVO ICL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to high myopia correctable with available EVO ICL powers. Moderate to high myopic with astigmatism correctable with available EVO ICL powers. Stable refractive history within 0.50 D cylinder for 1 year prior to implantation. Stable refractive history within 0.50 D for spherical equivalent 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: Ocular hypertension or glaucoma. Insulin dependent diabetes or diabetic retinopathy. History of previous ocular surgery. Monocular. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes. 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 EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EVO ICL<br>STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism. | Device: EVO ICL<br>* The EVO ICL 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elevated Intraocular Pressure (IOP) in Primary Eyes | The proportion of primary (i.e. first implanted) eyes that have IOP ≥ 30 mmHg and IOP ≥40 mmHG | 1-6 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elevated Intraocular Pressure (IOP) in Fellow Eyes | The proportion of fellow eyes that have IOP ≥ 30 mmHg and IOP ≥40 mmHG | 1-6 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nearsightedness, phakic IOL, toric ICL, ICL, TICL, EVO, astigmatism