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Completed

NCT Number: NCT04283149

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

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Myopic Astigmatism Refractive Errors

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnett Dulaney Perkins, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Primary Eyes Requiring Peripheral Iridotomy (PI)

    Time frame: 6 Months

    Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.

  2. Endothelial Cell Density (ECD) Change in Primary Eyes.

    Time frame: 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.

  3. Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.

    Time frame: 6 months

    Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes.

  4. Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.

    Time frame: 6 months

    Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes.

  5. Number of Ocular Adverse Events (AEs) in Primary Eyes.

    Time frame: 6 Months

Secondary outcomes

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

    Time frame: 6 Months

    Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes.

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

    Time frame: 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.

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

    Time frame: 6 months

    Number of eyes with ECD <1000 cell/mm² at month 6 in primary and fellow eyes.

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

    Time frame: 6 months

    Number of eyes with ECD <1500 cell/mm² at month 6 in primary and fellow eyes.

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

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Staar Surgical Company

Industry

Registry information

Official study title

A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Feb 25, 2020
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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