Measuring Outcomes of LASIK and EVO-ICL in Matched Populations (EVOlve)

Vance Thompson Vision

Status: Not yet enrolling

Conditions: Myopia

Treatments: Device: Laser-assisted in Situ Keratomileusis; Device: Implantable Collamer Lens placement

Study type: Interventional

Funder types: Other

Identifiers

NCT06700460

KJF-726

Details and patient eligibility

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.

Full description

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Laser-assisted in Situ Keratomileusis

Active Comparator group

Description:

LASIK-Wavefront Optimized

Treatment:

Device: Implantable Collamer Lens placement

Implantable Collamer Lens placement

Active Comparator group

Description:

EVO ICL

Treatment:

Device: Laser-assisted in Situ Keratomileusis