Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
125 participants
INTERVENTIONAL
2020-07-21
2024-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Visian TICL
STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.
Visian TICL
The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Interventions
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Visian TICL
The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
21 Years
45 Years
ALL
No
Sponsors
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Staar Surgical Company
INDUSTRY
Responsible Party
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Principal Investigators
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Joanne Egamino, PhD
Role: STUDY_DIRECTOR
VP, Clinical Affairs
Locations
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Aloha Laser Vision, LLC
Honolulu, Hawaii, United States
Price Vision Group,
Indianapolis, Indiana, United States
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
Bowie, Maryland, United States
Vance Thompson Vision
Omaha, Nebraska, United States
Vance Thompson Vision
West Fargo, North Dakota, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Hoopes Vision/Hoopes, Durrie, Rivera Research
Draper, Utah, United States
Countries
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Other Identifiers
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CP18-02
Identifier Type: -
Identifier Source: org_study_id
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