Evaluation of Mesopic Visual Acuity and Patient Satisfaction Following Ray-Tracing-Guided LASIK

To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes

Study Overview

• Status: Recruiting
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Wavelight Plus

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kayla Karpuk, OD; Phone Number: 605-361-3937; Email: kayla.karpuk@vancethompsonvision.com

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Vance Thompson Vision
      • Contact: Kayla Karpuk, OD; Phone Number: 605-361-3937; Email: kayla.karpuk@vancethompsonvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WaveLight Plus	Device: Wavelight Plus; comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establish non-inferiority of the post-operative uncorrected mesopic distance visual acuity MVA (UC-MVA, monocular) at 6 months to the pre-operative Best Spectacle-Corrected MVA (BSC-MVA, monocular), assessed in logMAR units	Baseline compared to 6 month post operative visit
Patient reported outcome of overall satisfaction with vision, measured using the Patient Reported Outcomes with LASIK - Satisfaction Survey (#1 of PROWL-SS, 0-100)	Baseline compared to 6 month post operative visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Satisfaction with night vision (modified based on #1 of PROWL-SS, 0 - 100) at baseline and 6-month post-op	Baseline compared to 6 month post operative visit
Difficulty driving at night (from PROWL, Top-2-box) at baseline and 6-month post-op	Baseline compared to 6 month post operative visit
Frequency of starbursts or halo that bother you (PROWL, Top-2-box) at baseline and 6-month post-op	Baseline compared to 6 month post operative visit
Mesopic contrast sensitivity measured with and without glare (binocular) at baseline and 6-month post-op+	Baseline compared to 6 month post operative visit
Uncorrected Distance Visual Acuity under photopic conditions at 6-month post-op	Baseline compared to 6 month post operative visit
Refractive predictability, percentage of eyes within ±0.25D, ±0.50D of target MRSE at 6-month post-op	Baseline compared to 6 month post operative visit

Other Outcome Measures

Outcome Measure	Time Frame
Other night vision questions and VND-Q (item 1-4, Top-2-box of each) at baseline and 6-month post-op	Baseline compared to 6 month post operative visit
Other domain scores of PROWL-SS (glare, halo, starbursts)	Baseline compared to 6 month post operative visit
BOSA tear film analysis at baseline and 6-month post-op	Baseline compared to 6 month post operative visit

Collaborators and Investigators

• Sponsor: Vance Thompson Vision
• Collaborators: Alcon, a Novartis Company

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism
• Other Study ID Numbers: 101390595

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes