Post-Market Evaluation of the EVO ICL

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).

Study Overview

• Status: Completed
• Conditions: Myopia; Myopic Astigmatism
• Intervention / Treatment: Device: EVO 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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Aloha Laser Vision, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Durrie Vision
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Kugler Vision, PC
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • 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
    • 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EVO ICL; STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.	Device: EVO ICL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg	The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.	1-6 hours postoperatively
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG	The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.	1-6 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg	The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.	1-6 hours postoperatively
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG	The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.	1-6 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD	Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.	1-6 hours postoperatively
Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes	Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.	1-6 hours postoperatively
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD	Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.	Day 1 postoperatively
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes	Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.	Day 1 postoperatively
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD	Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.	Day 5-9 postoperatively
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes	Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.	Day 5-9 postoperatively
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD	Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.	Day 10-18 postoperatively
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes	Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes	Day 10-18 postoperatively

Collaborators and Investigators

• Sponsor: Staar Surgical Company
• Investigators: Study Director: Joanne Egamino, PhD, Staar Surgical Company

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): September 21, 2023
• Study Completion (Actual): October 4, 2023

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: astigmatism; ICL; EVO; nearsightedness; phakic IOL; TICL; toric ICL
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism
• Other Study ID Numbers: CP22-01

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
• product manufactured in and exported from the U.S.: No