Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)

Study Overview
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Brief Summary
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This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.

Detailed Description
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This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.

Official Title
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A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens

Conditions
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Myopia, Myopic Astigmatism

Intervention / Treatment
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* Device: EVO/EVO+ Visian ICL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All enrolled eyes will undergo phakic eye surgery to have one of the available implantable collamer lenses EVO or EVO+ (spherical or toric) ICL implanted in their primary eye. Fellow eye surgery will occur between 7 and 14 days after primary eye surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Eyes<br>First implanted eyes of enrolled participants | Device: EVO/EVO+ Visian ICL<br>* The investigational lenses are 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>|
| Experimental: Fellow Eyes<br>Second implanted eyes of enrolled participants | Device: EVO/EVO+ Visian ICL<br>* The investigational lenses are 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 |
| --- | --- | --- |
| Number of Primary Eyes Requiring Peripheral Iridotomy (PI) | Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes. | 6 Months | 
| Endothelial Cell Density (ECD) Change in Primary Eyes. | Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes. Negative outcome values represent a reduction in Endothelial Cell Density. | 6 Months | 
| Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes. | Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes. | 6 months | 
| Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes. | Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes. | 6 months | 
| Number of Ocular Adverse Events (AEs) in Primary Eyes. |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI) | Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes. | 6 Months | 
| Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes. | Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes and fellow eyes. Negative outcome values represent a reduction in Endothelial Cell Density. | 6 Months | 
| Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes. | Number of eyes with ECD <1000 cell/mm² at month 6 in primary and fellow eyes. | 6 months | 
| Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes. | Number of eyes with ECD <1500 cell/mm² at month 6 in primary and fellow eyes. | 6 months | 
| Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes |  | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICL, Nearsightedness, Phakic intraocular lens (IOL), Toric ICL, EVO, EVO+, Visian