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

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

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.

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.

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.