Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

Launched by HOOPES VISION · Nov 7, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different eye surgeries, Topography-Guided LASIK and Small Incision Lenticule Extraction, to see how well they help people with nearsightedness (myopia) and astigmatism. In this study, one eye of each participant will receive one type of surgery, while the other eye will receive the other type. The goal is to compare the results of these two procedures and understand which one leads to better vision after surgery.

To be eligible for this study, participants need to be between the ages of 22 and 50 and have specific levels of nearsightedness and astigmatism. They should also have good vision in both eyes before the surgery and must be willing to follow the doctor's instructions, including using any prescribed eye drops after the surgery. Participants can expect to undergo a thorough examination before the surgery and will need to attend follow-up visits to check on their recovery and vision improvement. Importantly, individuals with certain eye conditions or health issues, such as severe dry eye or previous eye surgeries, may not be suitable for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 22-50 at the time of consent
• • 2. Diagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent 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 spherical equivalent no greater than 0.50 D comparing screening visit manifest refraction to previous refractions over one year period prior to surgery. (spectacle Rx, or contact lens Rx)
• • 7. Subjects who are contact lens wearers must have hard or gas permeable lenses discontinued for at least 4 weeks and soft lenses discontinued for at least 5 days prior to the preoperative screening evaluation. Hard or gas permeable lens wearers must not return to contact lens use before surgery and soft lens wearers must discontinue use at least 5 days before surgery.
• • 8. Acceptable topography and baseline examination results for refractive procedures as determined by Principal Investigator or Co-Investigator
• • 9. Surgical plan includes treatment target for emmetropia in both eyes and no monovision.
• • 10. Subject is capable and willing to use postoperative medications as prescribed.
• • 11. Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.
• • 12. Subjects are willing and able to return for all postoperative examinations.
• Exclusion Criteria:
• • 1. Clinically significant dry eye on clinical examination as determined by the investigator
• • 2. Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topography
• • 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 autoimmune disease.
• • 8. Females who are pregnant, breast-feeding, or intend to become pregnant any time during the course of the study as determined by verbal inquiry.
• • 9. The Principal Investigator has determined the subject not to be a good candidate for the study