Post-Market Evaluation of the EVO ICL

NCT05538754 | Completed Results FDA Device

• 1 other identifier: CP22-01
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 8

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).

Conditions

Myopia; Myopic Astigmatism

Keywords

nearsightedness; phakic IOL; toric ICL; ICL; TICL; EVO; astigmatism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg

  1-6 hours postoperatively

• Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG

  1-6 hours postoperatively

Other Outcomes (8)

• Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

  1-6 hours postoperatively

• Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

  1-6 hours postoperatively

• Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

  Day 1 postoperatively

Study Arms (1)

EVO ICL

OTHER

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

Device: EVO ICL

Interventions

EVO ICL DEVICE

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.

EVO ICL

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Staar Surgical Company: lead

Study Sites (8)

Aloha Laser Vision, LLC

Honolulu, Hawaii, 96814, United States

Location

Durrie Vision

Overland Park, Kansas, 66210, United States

Location

Kugler Vision, PC

Omaha, Nebraska, 68118, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75243, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Joanne Egamino
• Organization: STAAR Surgical

jegamino@staar.com

626-303-7902

Study Officials

• Joanne Egamino, PhD

  Staar Surgical Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: September 23, 2022
• Primary Completion: September 21, 2023
• Study Completion: October 4, 2023
• Last Updated: March 5, 2026
• Results First Posted: December 3, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)