Post-Market Evaluation of the EVO ICL

STAAR Surgical

Status

Completed

Conditions

Myopia

Myopic Astigmatism

Treatments

Device: EVO ICL

Study type

Interventional

Funder types

Industry

Identifiers

NCT05538754

CP22-01

Details and patient eligibility

About

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).

Full description

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.

Enrollment

205 patients

Sex

All

Ages

21 to 45 years old

Volunteers

No Healthy Volunteers

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.