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

Primary Purpose

Myopia, Myopic Astigmatism

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EVO/EVO+ Visian ICL
Sponsored by
Staar Surgical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Nearsightedness, Phakic intraocular lens (IOL), ICL, Toric ICL, EVO, EVO+, Visian

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barnett Dulaney Perkins
  • Aloha Laser Vision, LLC
  • Price Vision Group,
  • Durrie Vision
  • Solomon Eye Physicians and Surgeons/Bowie Vision Institute
  • Brinton Vision
  • Kugler Vision, PC
  • Cleveland Eye Clinic
  • Kremer Eye Center
  • Vance Thompson Vision
  • Key-Whitman Eye Center
  • Parkhurst NuVision
  • Hoopes Vision/Hoopes, Durrie, Rivera Research
  • The Eye Institute of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary Eyes

Fellow Eyes

Arm Description

First implanted eyes of enrolled participants

Second implanted eyes of enrolled participants

Outcomes

Primary Outcome Measures

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.
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.
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes.
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes.
Number of Ocular Adverse Events (AEs) in Primary Eyes.

Secondary Outcome Measures

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.
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.
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.
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.
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes

Full Information

First Posted
February 19, 2020
Last Updated
March 1, 2023
Sponsor
Staar Surgical Company
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1. Study Identification

Unique Protocol Identification Number
NCT04283149
Brief Title
Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
Official Title
A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
February 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Staar Surgical Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Myopic Astigmatism
Keywords
Nearsightedness, Phakic intraocular lens (IOL), ICL, Toric ICL, EVO, EVO+, Visian

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Eyes
Arm Type
Experimental
Arm Description
First implanted eyes of enrolled participants
Arm Title
Fellow Eyes
Arm Type
Experimental
Arm Description
Second implanted eyes of enrolled participants
Intervention Type
Device
Intervention Name(s)
EVO/EVO+ Visian ICL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)
Description
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.
Time Frame
6 Months
Title
Endothelial Cell Density (ECD) Change in Primary Eyes.
Description
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.
Time Frame
6 Months
Title
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
Description
Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes.
Time Frame
6 months
Title
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
Description
Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes.
Time Frame
6 months
Title
Number of Ocular Adverse Events (AEs) in Primary Eyes.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)
Description
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes.
Time Frame
6 Months
Title
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.
Description
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.
Time Frame
6 Months
Title
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.
Description
Number of eyes with ECD <1000 cell/mm² at month 6 in primary and fellow eyes.
Time Frame
6 months
Title
Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.
Description
Number of eyes with ECD <1500 cell/mm² at month 6 in primary and fellow eyes.
Time Frame
6 months
Title
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Egamino, PhD
Organizational Affiliation
VP, Global Clinical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Barnett Dulaney Perkins
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85106
Country
United States
Facility Name
Aloha Laser Vision, LLC
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Price Vision Group,
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Durrie Vision
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
City
Bowie
State/Province
Maryland
ZIP/Postal Code
20716
Country
United States
Facility Name
Brinton Vision
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Kugler Vision, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68118
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Kremer Eye Center
City
King Of Prussia
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Key-Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Parkhurst NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hoopes Vision/Hoopes, Durrie, Rivera Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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