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

Completed · Not applicable

Conditions studied: Myopia, Myopic Astigmatism

In brief

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.

Key facts

Study ID

NCT04283149

Run by

Staar Surgical Company

People needed

327

Starts

2020-01-30

Expected to finish

2023-12-15

Last updated by the study team

2026-03-16

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Barnett Dulaney Perkins — Phoenix, Arizona, United States
• Aloha Laser Vision, LLC — Honolulu, Hawaii, United States
• Price Vision Group, — Indianapolis, Indiana, United States
• Durrie Vision — Overland Park, Kansas, United States
• Solomon Eye Physicians and Surgeons/Bowie Vision Institute — Bowie, Maryland, United States
• Brinton Vision — St Louis, Missouri, United States
• Kugler Vision, PC — Omaha, Nebraska, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• Kremer Eye Center — King of Prussia, Pennsylvania, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States
• Key-Whitman Eye Center — Dallas, Texas, United States
• Parkhurst NuVision — San Antonio, Texas, United States
• Hoopes Vision/Hoopes, Durrie, Rivera Research — Draper, Utah, United States
• The Eye Institute of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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