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Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)

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: NCT04283149
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Staar Surgical Company

Brief Summary:
This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.

Condition or disease Intervention/treatment Phase
Myopia Myopic Astigmatism Device: EVO Visian ICL for Myopia Device: EVO Visian Toric ICL for Myopia with Astigmatism Device: EVO+ Visian ICL for Myopia Device: EVO+ Visian Toric ICL for Myopia with Astigmatism Not Applicable

Detailed Description:
This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 333 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled eyes will undergo phakic eye surgery to have one of the available implantable collamer lenses EVO or EVO+ (spherical or toric) ICL implanted in their primary eye. Fellow eye surgery will occur between 7 and 14 days after primary eye surgery.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EVO ICL Surgery for Myopia
Enrolled subjects with myopia will undergo ICL surgery in one or both eyes with EVO MICL model.
Device: EVO Visian ICL for Myopia
The EVO MICL 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:
  • VICMO
  • EVO MICL

Experimental: EVO+ ICL Surgery for Myopia
Enrolled subjects with myopia and astigmatism will undergo ICL surgery in one or both eyes with EVO+ MICL model.
Device: EVO+ Visian ICL for Myopia
The EVO+ MICL 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:
  • VICM5
  • EVO+ ICL

Experimental: EVO TICL Surgery for Myopia with Astigmatism
Enrolled subjects with myopia and astigmatism will undergo ICL surgery in one or both eyes with EVO TICL.
Device: EVO Visian Toric ICL for Myopia with Astigmatism
The EVO 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:
  • VTICMO
  • EVO TICL

Experimental: EVO+ TICL Surgery for Myopia with Astigmatism
Enrolled subjects with myopia and astigmatism will undergo ICL surgery in one or both eyes with EVO+ TICL.
Device: EVO+ Visian Toric ICL for Myopia with Astigmatism
The EVO+ 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:
  • VTICM5
  • EVO+ TICL




Primary Outcome Measures :
  1. Incidence of peripheral iridotomy (PI) in Primary Eyes [ Time Frame: 6 Months ]
    Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes

  2. Endothelial Cell Density (ECD) Loss in Primary Eyes [ Time Frame: 6 Months ]
    Distribution of percent ECD losses and the percent of eyes that have ECD <1500 and ECD <1000 in primary eyes

  3. Adverse Events (AEs) in Primary Eyes [ Time Frame: 6 Months ]
    Incidence of adverse events (AEs)


Secondary Outcome Measures :
  1. Incidence of peripheral iridotomy (PI) in Primary and Fellow Eyes [ Time Frame: 6 Months ]
    Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block

  2. Endothelial Cell Density (ECD) Loss in Primary and Fellow Eyes [ Time Frame: 6 Months ]
    Distribution of percent ECD losses and the percent of eyes that have ECD <1500 and ECD <1000

  3. Adverse Events (AEs) in all Treated Eyes [ Time Frame: 6 Months ]
    Incidence of adverse events (AEs)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 or myopic astigmatism correctable with available EVO/EVO+ ICL 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): NCT04283149


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, Arizona
Barnett Dulaney Perkins Recruiting
Phoenix, Arizona, United States, 85106
Contact: CP19-01 Study Coordinator    602-598-7646    pcrincoli@bdpec.com   
United States, Hawaii
Aloha Laser Vision, LLC Recruiting
Honolulu, Hawaii, United States, 96814
Contact: CP19-01 Study Coordinator    808-792-3937      
United States, Indiana
Price Vision Group, Recruiting
Indianapolis, Indiana, United States, 46260
Contact: CP19-01 Study Coordinator    317-844-5530      
United States, Kansas
Durrie Vision Recruiting
Overland Park, Kansas, United States, 66210
Contact: CP19-01 Study Coordinator    913-234-6347      
United States, Maryland
Solomon Eye Physicians and Surgeons/Bowie Vision Institute Recruiting
Bowie, Maryland, United States, 20716
Contact: CP19-01 Study Coordinator    301-464-1885      
United States, Missouri
Brinton Vision Recruiting
Saint Louis, Missouri, United States, 63141
Contact: CP19-01 Study Coordinator    314-375-2020      
United States, Nebraska
Kugler Vision, PC Recruiting
Omaha, Nebraska, United States, 68118
Contact: CP19-01 Study Coordinator    402-558-2211      
United States, Ohio
Cleveland Eye Clinic Recruiting
Brecksville, Ohio, United States, 44141
Contact: CP19-01 Study Coordinator    216-503-6535      
United States, Pennsylvania
Kremer Eye Center Recruiting
King Of Prussia, Pennsylvania, United States, 19406
Contact: CP19-01 Study Coordinator    732-750-0403      
United States, South Dakota
Vance Thompson Vision Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: CP19-01 Study Coordinator    605-361-3937      
United States, Texas
Key-Whitman Eye Center Recruiting
Dallas, Texas, United States, 75243
Contact: CP19-01 Study Coordinator    214-379-1855 ext 2295      
Parkhurst NuVision Recruiting
San Antonio, Texas, United States, 78229
Contact: CP19-01 Study Coordinator    201-585-2020      
United States, Utah
Hoopes Vision/Hoopes, Durrie, Rivera Research Recruiting
Draper, Utah, United States, 84020
Contact: CP19-01 Study Coordinator    801-988-7346      
The Eye Institute of Utah Recruiting
Salt Lake City, Utah, United States, 84107
Contact: CP19-01 Study Coordinator    801-263-5735    ladams@theeyeinstitute.com   
Contact: CP19-01 Study Coordinator       abagley@theeyeinstitute.com   
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: NCT04283149    
Other Study ID Numbers: CP19-01
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 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
Keywords provided by Staar Surgical Company:
Nearsightedness
Phakic intraocular lens (IOL)
ICL
Toric ICL
EVO
EVO+
Visian
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases