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

A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens

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.

Study Overview

• Status: Completed
• Conditions: Myopia; Myopic Astigmatism
• Intervention / Treatment: Device: EVO/EVO+ Visian ICL

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.

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85106
      • Barnett Dulaney Perkins
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Aloha Laser Vision, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Price Vision Group,
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Durrie Vision
  • Maryland
    • Bowie, Maryland, United States, 20716
      • Solomon Eye Physicians and Surgeons/Bowie Vision Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Brinton Vision
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Kugler Vision, PC
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • Pennsylvania
    • King Of Prussia, Pennsylvania, United States, 19406
      • Kremer Eye Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision
  • Texas
    • Dallas, Texas, United States, 75243
      • Key-Whitman Eye Center
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision
  • Utah
    • Draper, Utah, United States, 84020
      • Hoopes Vision/Hoopes, Durrie, Rivera Research
    • Salt Lake City, Utah, United States, 84107
      • The Eye Institute of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Eyes; First implanted eyes of enrolled participants	Device: EVO/EVO+ Visian ICL; The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Experimental: Fellow Eyes; Second implanted eyes of enrolled participants	Device: EVO/EVO+ Visian ICL; The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)	Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.	6 Months
Endothelial Cell Density (ECD) Change in Primary Eyes.	Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes. Negative outcome values represent a reduction in Endothelial Cell Density.	6 Months
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.	Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes.	6 months
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.	Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes.	6 months
Number of Ocular Adverse Events (AEs) in Primary Eyes.		6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)	Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes.	6 Months
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.	Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes and fellow eyes. Negative outcome values represent a reduction in Endothelial Cell Density.	6 Months
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.	Number of eyes with ECD <1000 cell/mm² at month 6 in primary and fellow eyes.	6 months
Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.	Number of eyes with ECD <1500 cell/mm² at month 6 in primary and fellow eyes.	6 months
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes		6 Months

Collaborators and Investigators

• Sponsor: Staar Surgical Company
• Investigators: Study Director: Joanne Egamino, PhD, VP, Global Clinical Affairs

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): April 5, 2021
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Toric ICL; Nearsightedness; Phakic intraocular lens (IOL); ICL; EVO; EVO+; Visian
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CP19-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes