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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
United States
Nebraska
Kugler Vision
NOT_YET_RECRUITING
Omaha
Ohio
Cleveland Eye Clinic
NOT_YET_RECRUITING
Cleveland
South Carolina
Carolina Eyecare Physicians
RECRUITING
Mt. Pleasant
South Dakota
Vance Thompson Vision Clinic
RECRUITING
Sioux Falls
Texas
Slade & Baker Vision
RECRUITING
Houston
Contact Information
Primary
Kristin L Dunne
kristin.dunne@vancethompsonvision.com
1-877-522-3937
Time Frame
Start Date: 2024-11-27
Estimated Completion Date: 2025-04-01
Participants
Target number of participants: 56
Treatments
Active_comparator: Laser-assisted in Situ Keratomileusis
LASIK-Wavefront Optimized
Active_comparator: Implantable Collamer Lens placement
EVO ICL
Related Therapeutic Areas
Sponsors
Leads: Vance Thompson Vision

This content was sourced from clinicaltrials.gov