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COMPLETEDNANCT04283149

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

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 diagno...

Lead sponsor: Staar Surgical Company•14 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Staar Surgical Company

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.

Age

21 - 45 years

Sex

ALL

Healthy Volunteers

No

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.

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 16, 2026Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment327

Start dateJan 2020

Last updatedMar 16, 2026

Condition

Myopia Myopic Astigmatism

Locations shown

Barnett Dulaney Perkins

Phoenix, Arizona

Aloha Laser Vision, LLC

Honolulu, Hawaii

Price Vision Group,

Indianapolis, Indiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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