Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

Status unconfirmed · Not applicable

Conditions studied: Myopia, Astigmatism

In brief

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.

Key facts

Study ID

NCT05611294

Run by

Hoopes Vision

People needed

42

Starts

2022-09-27

Expected to finish

2025-06-01

Last updated by the study team

2024-08-01

Who can join

Age: 22 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 22-50 at the time of consent
• Diagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent of refraction of ≥ -2.00 and ≤ -9.00 D
• Preop Spherical component of ≥ -2.00 and ≤ -8.00 D
• Refractive Cylinder of ≤ -3.00 D
• BCVA of 20/20 or better in each eye
• 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)
• 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.
• Acceptable topography and baseline examination results for refractive procedures as determined by Principal Investigator or Co-Investigator
• Surgical plan includes treatment target for emmetropia in both eyes and no monovision.
• Subject is capable and willing to use postoperative medications as prescribed.
• Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.
• Subjects are willing and able to return for all postoperative examinations.

You may not qualify if…

• Clinically significant dry eye on clinical examination as determined by the investigator
• Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topography
• History of corneal dystrophies or guttata
• History of herpetic keratitis or active disease
• History of prior refractive surgery
• History of glaucoma or glaucoma suspect
• History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.
• Females who are pregnant, breast-feeding, or intend to become pregnant any time during the course of the study as determined by verbal inquiry.
• The Principal Investigator has determined the subject not to be a good candidate for the study

Where it is running

• Hoopes Vision — Draper, Utah, United States

Full record on ClinicalTrials.gov

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