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Post-Market Evaluation of the EVO ICL

Primary Purpose

Myopia, Myopic Astigmatism

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EVO 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 IOL, toric ICL, ICL, TICL, EVO, astigmatism

Eligibility Criteria

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

Inclusion Criteria:

  • Moderate to high myopia correctable with available EVO ICL powers.
  • Moderate to high myopic with astigmatism correctable with available EVO ICL powers.
  • Stable refractive history within 0.50 D cylinder for 1 year prior to implantation.
  • Stable refractive history within 0.50 D for spherical equivalent 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:

  • Ocular hypertension or glaucoma.
  • Insulin dependent diabetes or diabetic retinopathy.
  • History of previous ocular surgery.
  • Monocular.
  • Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Aloha Laser Vision, LLC
  • Durrie Vision
  • Kugler Vision, PC
  • Cleveland Eye Clinic
  • Vance Thompson Vision
  • Key-Whitman Eye Center
  • Parkhurst NuVision
  • The Eye Institute of Utah

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EVO ICL

Arm Description

STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.

Outcomes

Primary Outcome Measures

Elevated Intraocular Pressure (IOP) in Primary Eyes
The proportion of primary (i.e. first implanted) eyes that have IOP ≥ 30 mmHg and IOP ≥40 mmHG

Secondary Outcome Measures

Elevated Intraocular Pressure (IOP) in Fellow Eyes
The proportion of fellow eyes that have IOP ≥ 30 mmHg and IOP ≥40 mmHG

Full Information

First Posted
September 9, 2022
Last Updated
September 7, 2023
Sponsor
Staar Surgical Company
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1. Study Identification

Unique Protocol Identification Number
NCT05538754
Brief Title
Post-Market Evaluation of the EVO ICL
Official Title
Post-Market Evaluation of the EVO ICL
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).
Detailed Description
This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.

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 IOL, toric ICL, ICL, TICL, EVO, astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EVO ICL
Arm Type
Other
Arm Description
STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.
Intervention Type
Device
Intervention Name(s)
EVO ICL
Intervention Description
The EVO ICL 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.
Primary Outcome Measure Information:
Title
Elevated Intraocular Pressure (IOP) in Primary Eyes
Description
The proportion of primary (i.e. first implanted) eyes that have IOP ≥ 30 mmHg and IOP ≥40 mmHG
Time Frame
1-6 hours postoperatively
Secondary Outcome Measure Information:
Title
Elevated Intraocular Pressure (IOP) in Fellow Eyes
Description
The proportion of fellow eyes that have IOP ≥ 30 mmHg and IOP ≥40 mmHG
Time Frame
1-6 hours postoperatively

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 correctable with available EVO ICL powers. Moderate to high myopic with astigmatism correctable with available EVO ICL powers. Stable refractive history within 0.50 D cylinder for 1 year prior to implantation. Stable refractive history within 0.50 D for spherical equivalent 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: Ocular hypertension or glaucoma. Insulin dependent diabetes or diabetic retinopathy. History of previous ocular surgery. Monocular. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes. Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Egamino, PhD
Organizational Affiliation
Staar Surgical Company
Official's Role
Study Director
Facility Information:
Facility Name
Aloha Laser Vision, LLC
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Durrie Vision
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
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
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
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

Post-Market Evaluation of the EVO ICL

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