Lens implants vs. laser: which fix for nearsightedness comes out on top?
NCT ID NCT06700460
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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54 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Nov 2025
- Lead sponsor
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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
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21 to 45 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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
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Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464, United States
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Cleveland Eye Clinic
Cleveland, Ohio, 44035, United States
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Kugler Vision
Omaha, Nebraska, 68118, United States
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Slade & Baker Vision
Houston, Texas, 77027, United States
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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.
- A monocentre, Single-Arm trial to study the effect of lens inspired by myopia control solutions on the astigmatism of a child
- Can a lens put the brakes on worsening Short-Sightedness?
- Can a new lens implant sharpen vision for nearsighted eyes?
- LASIK gets a precision upgrade to sharpen night vision
- A daily eye drop might slow childhood nearsightedness. a trial puts it to the test.
- Can a single lens implant restore near and distance vision?