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

STAAR Surgical

Status

Completed

Conditions

Myopia

Myopic Astigmatism

Treatments

Device: EVO/EVO+ Visian ICL

Study type

Interventional

Funder types

Industry

Identifiers

NCT04283149

CP19-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

327 patients

Sex

All

Ages

21 to 45 years old

Volunteers

No Healthy Volunteers

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.