CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 327 enrolled
Drug / intervention
EVO/EVO+ Visian ICLdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04283149
NCT04283149N/ACompleted
CompareCT.gov

A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens

Staar Surgical Company·interventional·Posted Feb 25, 2020·Updated Mar 16, 2026

In Brief

A clinical study evaluating EVO/EVO+ Visian ICL for Myopia and Myopic Astigmatism. Completed, enrolled 327 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyopia, Myopic Astigmatism
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 25, 2020
Enrollment StartJan 30, 2020
Primary CompletionApr 5, 2021
Study CompletionDec 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.4 years ago

Interventions

EVO/EVO+ Visian ICLdevice

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.