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Trial record 1 of 3 for:    STAAR [Lead]
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STAAR Visian Toric ICL Post-Approval Study (TICL-PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04516772
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Staar Surgical Company

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).

Condition or disease Intervention/treatment Phase
Myopic Astigmatism Device: Visian TICL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled subjects will undergo phakic eye surgery to have the STAAR Visian Toric Implantable Collamer Lens (TICL) implanted in one or both eligible eyes.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Approval Study of the Visian Toric Implantable Collamer Lens
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Visian TICL
STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.
Device: 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 Names:
  • Visian Toric ICL
  • TMICL




Primary Outcome Measures :
  1. Change in axis orientation of the TICL [ Time Frame: 18 to 24 months postoperative ]
    Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative


Secondary Outcome Measures :
  1. Absolute Rotation of the TICL in treated eyes [ Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery ]
    • Absolute rotation of the TICL between visits
    • Absolute rotation of the TICL <5 degrees, <10 degrees, <20 degrees, and <30 degrees from intended orientation
    • Absolute rotation of the TICL at each visit

  2. Manifest refraction spherical equivalence (MRSE) and cylinder [ Time Frame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery ]
    MRSE and cylinder in treated eyes

  3. Ocular (adverse events) AEs [ Time Frame: Through study completion, an average of 24 months ]
    Incidence of AEs in treated eyes



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516772


Contacts
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Contact: Joanne Egamino, PhD (626) 303-7902 ext 2215 ClinicalAffairs@staar.com
Contact: Amber Weinmann, MSc (626) 303-7902 ext 2215 ClinicalAffairs@staar.com

Locations
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United States, Indiana
Price Vision Group, Recruiting
Indianapolis, Indiana, United States, 46260
Contact: CP18-02 Study Coordinator    317-844-5530      
United States, Maryland
Solomon Eye Physicians and Surgeons/Bowie Vision Institute Recruiting
Bowie, Maryland, United States, 20716
Contact: CP18-02 Study Coordinator    301-464-1885      
United States, North Dakota
Vance Thompson Vision Recruiting
W. Fargo, North Dakota, United States, 58078
Contact: CP18-02 Study Coordinator    701-639-2017      
Contact    701-566-5628      
United States, Ohio
Cleveland Eye Clinic Recruiting
Brecksville, Ohio, United States, 44141
Contact: CP18-02 Study Coordinator    216-503-6535      
United States, Texas
Key-Whitman Eye Center Recruiting
Dallas, Texas, United States, 75243
Contact: CP18-02 Study Coordinator    214-220-3937      
United States, Utah
Hoopes Vision/Hoopes, Durrie, Rivera Research Recruiting
Draper, Utah, United States, 84020
Contact: CP18-02 Study Coordinator    801-988-7346      
Sponsors and Collaborators
Staar Surgical Company
Investigators
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Study Director: Jon Hayashida, OD., FAAO Vice President, Clinical and Medical Affairs
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Responsible Party: Staar Surgical Company
ClinicalTrials.gov Identifier: NCT04516772    
Other Study ID Numbers: CP18-02
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Staar Surgical Company:
nearsightedness
phakic IOL
Toric ICL
TICL
TMICL
Visian
astigmatism
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases