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Search / Trial NCT04516772

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

Nearsightedness Phakic Iol Toric Icl Ticl Tmicl Visian Astigmatism

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.

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

0 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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