Post-Market Evaluation of the EVO ICL

Post-Market Evaluation of the EVO ICL

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).

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.

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.