Post-Market Evaluation of the EVO ICL

Completed · Not applicable

Conditions studied: Myopia, Myopic Astigmatism

In brief

The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).

Key facts

Study ID

NCT05538754

Run by

Staar Surgical Company

People needed

205

Starts

2022-09-23

Expected to finish

2023-10-04

Last updated by the study team

2026-03-05

Who can join

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

You may qualify if…

• Moderate to high myopia correctable with available EVO ICL powers.
• Moderate to high myopic with astigmatism correctable with available EVO ICL powers.
• Stable refractive history within 0.50 D cylinder for 1 year prior to implantation.
• Stable refractive history within 0.50 D for spherical equivalent 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…

• Ocular hypertension or glaucoma.
• Insulin dependent diabetes or diabetic retinopathy.
• History of previous ocular surgery.
• Monocular.
• Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
• Other protocol-specified exclusion criteria may apply.

Where it is running

• Aloha Laser Vision, LLC — Honolulu, Hawaii, United States
• Durrie Vision — Overland Park, Kansas, United States
• Kugler Vision, PC — Omaha, Nebraska, United States
• Cleveland Eye Clinic — Brecksville, Ohio, 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
• The Eye Institute of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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