RECRUITING

Measuring Outcomes of LASIK and EVO-ICL in Matched Populations

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Conditions

MyopiaLASIKEVO ICLClinical Outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-27
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06700460

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. 1. Subjects ages 21 to 45 years old.
  3. 2. Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator.
  4. 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).
  5. 4. Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.
  6. 5. Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest refraction spherical equivalent (MRSE) of ≤0.75 D.
  7. 6. Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
  8. 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.
  1. * 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. 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. 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. 4. Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator. For example:
  5. * Pigment dispersion,
  6. * History or clinical signs of iritis/uveitis,
  7. * History of previous ocular surgery,
  8. * Monocular subjects,
  9. * History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.),
  10. * Evidence of retinal vascular disease,
  11. * Keratoconus or keratoconus suspect,
  12. * Glaucoma or glaucoma suspect by exam findings,
  13. * Ocular surface disease other than controlled dry eye syndrome. 5. Subjects who do not qualify for both study arms:
  14. * Bilateral Wavefront Optimized LASIK
  15. * Bilateral EVO+ ICL implantation
  16. 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.
  17. 7. Participation in another clinical trial involving ocular procedures within the last 6-months.
  18. 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.

Contacts and Locations

Study Contact

Kristin L Dunne
CONTACT
1-877-522-3937
kristin.dunne@vancethompsonvision.com

Study Locations (Sites)

Kugler Vision
Omaha, Nebraska, 68118
United States
Cleveland Eye Clinic
Cleveland, Ohio, 44035
United States
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464
United States
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, 57108
United States
Slade & Baker Vision
Houston, Texas, 77027
United States

Collaborators and Investigators

Sponsor: Vance Thompson Vision

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-27
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2024-11-27
Study Completion Date2025-04-01

Terms related to this study

Keywords Provided by Researchers

  • LASIK
  • EVO ICL
  • Myopia
  • Clinical Outcomes

Additional Relevant MeSH Terms

  • Myopia