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NCT06700460 · Vance Thompson Vision

Measuring Outcomes of LASIK and EVO-ICL in Matched Populations

(EVOlve)

What this study is about

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

View original scientific description

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

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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. 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.

Where

  • Omaha, Nebraska
  • Cleveland, Ohio
  • Mt. Pleasant, South Carolina
  • Sioux Falls, South Dakota
  • Houston, Texas

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jan 9, 2025 · Source of record for eligibility and locations

📊
1 of 56 participants interested
2% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

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Omaha

Nebraska

Location available
View Omaha location page
NOT_YET_RECRUITING

Cleveland

Ohio

Location available
RECRUITING

Mt. Pleasant

South Carolina

Location available
RECRUITING

Sioux Falls

South Dakota

Location available
RECRUITING

Houston

Texas

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Looking for Myopia Treatment in Omaha?

Join others in Nebraska exploring innovative treatment options through clinical research

Myopia Treatment Options in Omaha, Nebraska

If you're searching for Myopia treatment in Omaha, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Omaha, Cleveland, Mt. Pleasant and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Myopia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Nebraska
Now Enrolling
Up to 56 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Myopia?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Myopia

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Myopia Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06700460. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.