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Completed

NCT Number: NCT06700460

Measuring Outcomes of LASIK and EVO-ICL in Matched Populations

Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kugler Vision, Omaha, Nebraska, United States

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About this study

A randomized evaluation of clinical outcomes following bilateral implantation of EVO+ Visian™ Implantable Collamer™ Lenses or bilateral Wavefront-optimized LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.

Who can participate

Healthy volunteers accepted: No

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

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:
  • Subjects ages 21 to 45 years old.
  • Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator.
  • 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).
  • Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.
  • Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest refraction spherical equivalent (MRSE) of ≤0.75 D.
  • Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • Participation in another clinical trial involving ocular procedures within the last 6-months.
  • 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.

Treatment and study plan

Laser-assisted in Situ Keratomileusis

Device

LASIK

Implantable Collamer Lens placement

Device

EVO ICL

Primary outcomes

  1. Visual Acuity

    Time frame: 1 month

    Uncorrected distance visual acuity and Corrected distance visual acuity

  2. Manifest refractive spherical equivalent

    Time frame: 1 month

    Manifest refraction spherical equivalent (MRSE) is a measurement used in eye care to determine the overall refractive error of the eye, taking into account both nearsightedness or farsightedness (spherical component) and astigmatism (cylindrical component).

    It's calculated by adding the sphere power and half of the cylinder power

  3. Abberometry (Higher Order Abberations and Corneal Performance Index)

    Time frame: 1 month

    Aberrometry is a technique used to measure the optical aberrations of the eye, including both lower-order aberrations (LOAs) and higher-order aberrations (HOAs).

    LOAs are the standard refractive errors, such as nearsightedness, farsightedness, and astigmatism, which can be corrected with glasses or contact lenses. HOAs, on the other hand, are more complex aberrations that affect the quality of vision, even if the LOAs are corrected. HOAs are caused by irregularities in the shape of the cornea or lens.

    They can cause a variety of visual symptoms, including blurry vision, glare, halos, and difficulty seeing at night

  4. Objective Scatter Index

    Time frame: 1 month

    The Objective Scatter Index (OSI) is a measurement used in ophthalmology to assess the quality of the eye's optical media, particularly the cornea and lens.

    It quantifies the amount of light scatter within the eye, which can affect visual clarity and contrast sensitivity.

  5. Contrast Sensitivity

    Time frame: 1 month

    Contrast sensitivity is the ability to distinguish between objects with varying degrees of contrast, especially in situations of low light or when objects have subtle differences in shading.

  6. Tear Film Stability

    Time frame: 1 month

    Tear film stability refers to the ability of the tear film, a thin layer of fluid that covers the surface of the eye, to remain intact and maintain a smooth, even surface. This is essential for clear vision and healthy ocular surface.

  7. Ocular Adverse Events in treated eyes/safety

    Time frame: 1 month

    Ocular adverse events (OAEs) are side effects that can occur in the eye after receiving a treatment, such as medication, surgery, or radiation therapy.

    These events can range from mild and temporary to severe and permanent.

  8. Subjective Questionnaires and Open-Ended Questions

    Time frame: 1 month

    Subjective questionnaires and open-ended questions are two common methods used in research to gather qualitative data. They allow researchers to delve deeper into participants' thoughts, feelings, and experiences, providing rich insights that quantitative methods may not capture.

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Registry information

Official study title

A Randomized Evaluation of Clinical Outcomes Following Bilateral Implantation of EVO+ ICL Lenses or Bilateral Wavefront-Optimized LASIK (EVOlve)

Acronym: EVOlve

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Jul 17, 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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