Post-Market Evaluation of the EVO ICL
Launched by STAAR SURGICAL COMPANY · Sep 9, 2022
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About Staar Surgical Company
STAAR Surgical Company is a leading innovator in the development and manufacturing of advanced ophthalmic surgical products, specializing in implantable lenses for vision correction. With a commitment to enhancing patient outcomes through cutting-edge technology, STAAR Surgical focuses on providing safe and effective solutions for conditions such as cataracts and myopia. The company is dedicated to rigorous clinical research and trials to ensure the efficacy and safety of its products, making significant contributions to the field of ophthalmology and improving the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brecksville, Ohio, United States
Sioux Falls, South Dakota, United States
Salt Lake City, Utah, United States
San Antonio, Texas, United States
Dallas, Texas, United States
Honolulu, Hawaii, United States
Overland Park, Kansas, United States
Omaha, Nebraska, United States
Patients applied
Trial Officials
Joanne Egamino, PhD
Study Director
Staar Surgical Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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