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

NCT04283149 | Completed Results FDA Device

• 1 other identifier: CP19-01
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 14

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.

Conditions

Myopia; Myopic Astigmatism

Keywords

Nearsightedness; Phakic intraocular lens (IOL); ICL; Toric ICL; EVO; EVO+; Visian

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)

  6 Months

• Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.

  6 Months

• Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.

  6 months

• Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.

  6 months

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

  6 Months

Study Arms (2)

Primary Eyes

EXPERIMENTAL

First implanted eyes of enrolled participants

Device: EVO/EVO+ Visian ICL

Fellow Eyes

EXPERIMENTAL

Second implanted eyes of enrolled participants

Device: EVO/EVO+ Visian ICL

Interventions

EVO/EVO+ Visian ICL DEVICE

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.

Fellow Eyes; Primary Eyes

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Staar Surgical Company: lead

Study Sites (14)

Barnett Dulaney Perkins

Phoenix, Arizona, 85106, United States

Location

Aloha Laser Vision, LLC

Honolulu, Hawaii, 96814, United States

Location

Price Vision Group,

Indianapolis, Indiana, 46260, United States

Location

Durrie Vision

Overland Park, Kansas, 66210, United States

Location

Solomon Eye Physicians and Surgeons/Bowie Vision Institute

Bowie, Maryland, 20716, United States

Location

Brinton Vision

St Louis, Missouri, 63141, United States

Location

Kugler Vision, PC

Omaha, Nebraska, 68118, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Kremer Eye Center

King of Prussia, Pennsylvania, 19406, 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

Hoopes Vision/Hoopes, Durrie, Rivera Research

Draper, Utah, 84020, 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

  VP, Global Clinical Affairs

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: January 30, 2020
• Primary Completion: April 5, 2021
• Study Completion: December 15, 2023
• Last Updated: March 16, 2026
• Results First Posted: July 27, 2022

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)