Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

Last updated: July 31, 2024
Sponsor: Hoopes Vision
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Astigmatism

Myopia

Treatment

Topography Guided LASIK Surgery

Small Incision Lenticule Extraction Surgery

Clinical Study ID

NCT05611294
HDRR-CON2022
  • Ages 22-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 22-50 at the time of consent

  2. Diagnosis of myopia or myopia with astigmatism with Preop manifest sphericalequivalent of refraction of ≥ -2.00 and ≤ -9.00 D

  3. Preop Spherical component of ≥ -2.00 and ≤ -8.00 D

  4. Refractive Cylinder of ≤ -3.00 D

  5. BCVA of 20/20 or better in each eye

  6. Subjects must have a stable refraction which is defined as change in sphericalequivalent no greater than 0.50 D comparing screening visit manifest refraction toprevious refractions over one year period prior to surgery. (spectacle Rx, orcontact lens Rx)

  7. Subjects who are contact lens wearers must have hard or gas permeable lensesdiscontinued for at least 4 weeks and soft lenses discontinued for at least 5 daysprior to the preoperative screening evaluation. Hard or gas permeable lens wearersmust not return to contact lens use before surgery and soft lens wearers mustdiscontinue use at least 5 days before surgery.

  8. Acceptable topography and baseline examination results for refractive procedures asdetermined by Principal Investigator or Co-Investigator

  9. Surgical plan includes treatment target for emmetropia in both eyes and nomonovision.

  10. Subject is capable and willing to use postoperative medications as prescribed.

  11. Subject has ability to successfully complete all preoperative and postoperativequestionnaires, testing, and exam visits.

  12. Subjects are willing and able to return for all postoperative examinations.

Exclusion

Exclusion Criteria:

  1. Clinically significant dry eye on clinical examination as determined by theinvestigator

  2. Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal cornealtopography

  3. History of corneal dystrophies or guttata

  4. History of herpetic keratitis or active disease

  5. History of prior refractive surgery

  6. History of glaucoma or glaucoma suspect

  7. History of uncontrolled diabetes, unstable hypertension, or unstable autoimmunedisease.

  8. Females who are pregnant, breast-feeding, or intend to become pregnant any timeduring the course of the study as determined by verbal inquiry.

  9. The Principal Investigator has determined the subject not to be a good candidate forthe study

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Topography Guided LASIK Surgery
Phase:
Study Start date:
September 27, 2022
Estimated Completion Date:
June 01, 2025

Study Description

This is a prospective, randomized, simultaneous, contralateral eye study including at least 42 patients undergoing refractive correction surgery. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. Randomization will ensure 50% of Right Eyes will receive Topography-Guided LASIK and 50% of Right Eyes will receive Small Incision Lenticule Extraction. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.

Connect with a study center

  • Hoopes Vision

    Draper, Utah 84020
    United States

    Site Not Available

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