Lens implants vs. laser: which fix for nearsightedness comes out on top?

NCT ID NCT06700460

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial compares two ways to correct nearsightedness: implanting a small lens inside the eye (EVO+ ICL) and reshaping the cornea with a laser (LASIK). Researchers are measuring how well each procedure improves vision, as well as side effects like glare, dry eye, and night vision problems. The study includes 54 adults who are candidates for both procedures and will be randomly assigned to receive one or the other.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
two vision correction procedures: an implantable lens (EVO+ ICL) and laser eye surgery (LASIK)
What this could lead to
If this trial shows that ICL lenses are as good as or better than LASIK, it could offer people with nearsightedness a safe, effective alternative to laser surgery.
What could go wrong
This is a small, early-stage study with only 54 participants, so results may not apply to everyone. Both procedures carry risks like infection, dry eye, or visual disturbances.

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

54 people

The number who actually took part.

Started

Nov 2024

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Preoperatively the Investigator will evaluate each study subject and refer to the directions for use for EVO+ ICL and Wavefront-Optimized LASIK to confirm the subject's suitability to proceed with bilateral EVO+ ICL Implantation or bilateral Wavefront-optimized LASIK in accordance with the Investigator's standard of care for each procedure. To ensure similar characteristics across study subjects, the Investigator will also adhere to the following criteria for each group: 1. Subjects ages 21 to 45 years old. 2. Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator. 3. Myopia or myopia with astigmatism with spherical equivalent ranging from -3.00 D to ≤ -8.00 D (in the spectacle plane) and cylinder in the range of 0.00 D to 4.00 D (in the spectacle plane). 4. Corrected distance visual acuity (CDVA) of 20/20 or better in each eye. 5. Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest refraction spherical equivalent (MRSE) of ≤0.75 D. 6. Subjects must be able and willing to return for scheduled follow-up examinations after surgery. 7. Subjects must be 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. Exclusion Criteria: * 1\. 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. 2\. Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator. 3\. Serious acute, chronic, or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, uncontrolled diabetes, etc.), in the opinion of the Investigator. 4\. Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator. For example: * Pigment dispersion, * History or clinical signs of iritis/uveitis, * History of previous ocular surgery, * Monocular subjects, * History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.), * Evidence of retinal vascular disease, * Keratoconus or keratoconus suspect, * Glaucoma or glaucoma suspect by exam findings, * Ocular surface disease other than controlled dry eye syndrome. 5. Subjects who do not qualify for both study arms: * Bilateral Wavefront Optimized LASIK * Bilateral EVO+ ICL implantation 6\. Subjects who, in the judgment of the Investigator, present any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment. 7\. Participation in another clinical trial involving ocular procedures within the last 6-months. 8\. Other conditions or assessment that causes the subject to not be an acceptable candidate for treatment or study participation as clinically assessed and documented by the Investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Myopia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina, 29464, United States

  • Cleveland Eye Clinic

    Cleveland, Ohio, 44035, United States

  • Kugler Vision

    Omaha, Nebraska, 68118, United States

  • Slade & Baker Vision

    Houston, Texas, 77027, United States

  • Vance Thompson Vision Clinic

    Sioux Falls, South Dakota, 57108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.