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

NCT04283149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2026-03-16

Study results available
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Summary

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.

Conditions

  • Myopia
  • Myopic Astigmatism

Interventions

DEVICE

EVO/EVO+ Visian ICL

The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.

Sponsors & Collaborators

  • Staar Surgical Company

    lead INDUSTRY

Principal Investigators

  • Joanne Egamino, PhD · VP, Global Clinical Affairs

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2021-04-05
Completion
2023-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283149 on ClinicalTrials.gov