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Implantable lens offers new hope for nearsightedness

NCT ID NCT04283149

Disease control Sponsor: Staar Surgical Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and effectiveness of the EVO/EVO+ Visian Implantable Collamer Lens (ICL) in 327 adults with moderate to high nearsightedness (with or without astigmatism). The lens is surgically placed inside the eye to correct vision. Researchers tracked side effects, eye cell health, and vision changes over 6 to 36 months. The goal was to see if the lens is a safe and reliable option for vision correction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

327 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

astigmatism myopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myopia Myopic astigmatism

Contacts and locations

Locations

  • Aloha Laser Vision, LLC

    Honolulu, Hawaii, 96814, United States

  • Barnett Dulaney Perkins

    Phoenix, Arizona, 85106, United States

  • Brinton Vision

    St Louis, Missouri, 63141, United States

  • Cleveland Eye Clinic

    Brecksville, Ohio, 44141, United States

  • Durrie Vision

    Overland Park, Kansas, 66210, United States

  • Hoopes Vision/Hoopes, Durrie, Rivera Research

    Draper, Utah, 84020, United States

  • Key-Whitman Eye Center

    Dallas, Texas, 75243, United States

  • Kremer Eye Center

    King of Prussia, Pennsylvania, 19406, United States

  • Kugler Vision, PC

    Omaha, Nebraska, 68118, United States

  • Parkhurst NuVision

    San Antonio, Texas, 78229, United States

  • Price Vision Group,

    Indianapolis, Indiana, 46260, United States

  • Solomon Eye Physicians and Surgeons/Bowie Vision Institute

    Bowie, Maryland, 20716, United States

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107, United States

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108, United States

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