Status:
COMPLETED
STAAR Visian Toric ICL Post-Approval Study
Lead Sponsor:
Staar Surgical Company
Conditions:
Myopic Astigmatism
Eligibility:
All Genders
21-45 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04516772
Start Date
July 21 2020
End Date
December 11 2024
Last Update
March 10 2025
Active Locations (8)
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1
Aloha Laser Vision, LLC
Honolulu, Hawaii, United States, 96814
2
Price Vision Group,
Indianapolis, Indiana, United States, 46260
3
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
Bowie, Maryland, United States, 20716
4
Vance Thompson Vision
Omaha, Nebraska, United States, 68137