Seeing clearly in low light after Ray-Tracing guided LASIK

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial evaluates mesopic visual acuity and patient satisfaction after LASIK guided by Ray-Tracing technology. Eligible adults 18–45 with stable myopia ± astigmatism and specific refractive ranges undergo bilateral LASIK targeted to emmetropia. The study measures functional night vision outcomes and patient-reported experience using WaveLight Plus. The sponsor is Vance Thompson Vision with collaboration from Alcon, and the trial is conducted at a single center in Sioux Falls, SD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects ages 18 to 45 years old.
2. Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery or stability as determined by the investigator.
3. Myopia with or without astigmatism and MRSE within the range of indications for wavelight plus (myopia up to -8.00D, astigmatism up to -3.00D, S.E. more than -1.00 and up to -9.00D)
4. Best corrected distance visual acuity (BCDVA) of 20/20 or better (≥83 letters) in each eye.
5. Subjects who have elected to undergo bilateral LASIK targeted for emmetropia.
6. Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
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.
8. Mesopic pupil size ≥4.5mm
9. Less than 0.75D spherical equivalent differences between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)
10. Subjects who regularly drive at night and expect to continue night driving throughout the duration of the study, as determined by investigator assessment

Exclusion Criteria:

1. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or have another condition with associated fluctuation of hormones that could lead to refractive changes.
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. Previous corneal ocular surgery
4. History of evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma or glaucoma suspect.
5. 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.
6. Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator.
7. Subjects who, in the judgment of the Investigator, present any emotional, physiological, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
8. Patients with a calculated residual stromal depth \<250 um

Where it's running

• Vance Thompson Vision
  Sioux Falls, South Dakota, United States Recruiting

Study contacts

• Study coordinator: Kayla Karpuk, OD
• Email: kayla.karpuk@vancethompsonvision.com
• Phone: 605-361-3937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.