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

Not Applicable

Completed

• Conditions: Myopia; Myopic Astigmatism
• Interventions: Device: EVO/EVO+ Visian ICL

• Registration Number: NCT04283149
• Lead Sponsor: Staar Surgical Company

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.

Study Timeline

• Study Start: 2020-01-30
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Primary Completion: 2021-04-05
• Results First Submitted: 2022-04-08
• Results First Submitted QC: 2022-07-01
• Results First Posted: 2022-07-27
• Study Completion: 2023-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fellow Eyes	EVO/EVO+ Visian ICL	Second implanted eyes of enrolled participants
Primary Eyes	EVO/EVO+ Visian ICL	First implanted eyes of enrolled participants

Primary Outcome Measures

Name	Time	Method
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.	6 months	Number of eyes with ECD \<1000 cells/mm² at month 6 in primary eyes.
Endothelial Cell Density (ECD) Change in Primary Eyes.	6 Months	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) <1500 Cells/mm² in Primary Eyes.	6 months	Number of eyes with ECD \<1500 cells/mm² at month 6 in primary eyes.
Number of Ocular Adverse Events (AEs) in Primary Eyes.	6 Months
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)	6 Months	Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.

Secondary Outcome Measures

Name	Time	Method
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.	6 months	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.	6 months	Number of eyes with ECD \<1500 cell/mm² at month 6 in primary and fellow eyes.
Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)	6 Months	Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes.
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes	6 Months
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.	6 Months	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.

Trial Locations

Locations (14)

Key-Whitman Eye Center; 🇺🇸 Dallas, Texas, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Hoopes Vision/Hoopes, Durrie, Rivera Research; 🇺🇸 Draper, Utah, United States

Brinton Vision; 🇺🇸 Saint Louis, Missouri, United States

Durrie Vision; 🇺🇸 Overland Park, Kansas, United States

Price Vision Group,; 🇺🇸 Indianapolis, Indiana, United States

Solomon Eye Physicians and Surgeons/Bowie Vision Institute; 🇺🇸 Bowie, Maryland, United States

Kremer Eye Center; 🇺🇸 King Of Prussia, Pennsylvania, United States

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States

Aloha Laser Vision, LLC; 🇺🇸 Honolulu, Hawaii, United States

Kugler Vision, PC; 🇺🇸 Omaha, Nebraska, United States

The Eye Institute of Utah; 🇺🇸 Salt Lake City, Utah, United States

Barnett Dulaney Perkins; 🇺🇸 Phoenix, Arizona, United States

Parkhurst NuVision; 🇺🇸 San Antonio, Texas, United States