NCT04283149

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: Staar Surgical Company · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myopia
• Myopic Astigmatism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-30
• Primary completion: 2021-04-05
• Completion: 2023-12-15
• First posted: 2020-02-25
• Last updated: 2026-03-16
• Results posted: 2022-07-27

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study