STAAR Visian Toric ICL Post-Approval Study
Launched by STAAR SURGICAL COMPANY · Aug 13, 2020
Trial Information
Current as of September 12, 2025
Completed
Keywords
ClinConnect Summary
This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Moderate to high myopia with astigmatism correctable with available TICL 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.
- Exclusion Criteria:
- • 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.
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
Dallas, Texas, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
Bowie, Maryland, United States
Draper, Utah, United States
Omaha, Nebraska, United States
W. Fargo, North Dakota, United States
Patients applied
Trial Officials
Joanne Egamino, PhD
Study Director
VP, Clinical Affairs
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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