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RecruitingNCT07790185Updated Aug 27, 2026

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

A Phase 4 interventional study of Wavelight Plus in Astigmatism and Myopia, sponsored by Vance Thompson Vision. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Vance Thompson Vision · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2026, registered Aug 2026).
  • Started Apr 2026; still recruiting 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Astigmatism
  • Myopia
03

In context

Astigmatism

417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.

This study's planned enrollment of 50 is close to the median of 55 across 325 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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., , connective tissue disease, 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    WaveLight Plus

    Device: Wavelight Plus

Interventions

  • DeviceWavelight Plus

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline compared to 6 month post operative visit

  2. Patient reported outcome of overall satisfaction with vision, measured using the Patient Reported Outcomes with LASIK - Satisfaction Survey (#1 of PROWL-SS, 0-100)

    Time frame: Baseline compared to 6 month post operative visit

Secondary outcomes

  1. Satisfaction with night vision (modified based on #1 of PROWL-SS, 0 - 100) at baseline and 6-month post-op

    Time frame: Baseline compared to 6 month post operative visit

  2. Difficulty driving at night (from PROWL, Top-2-box) at baseline and 6-month post-op

    Time frame: Baseline compared to 6 month post operative visit

  3. Frequency of starbursts or halo that bother you (PROWL, Top-2-box) at baseline and 6-month post-op

    Time frame: Baseline compared to 6 month post operative visit

  4. Mesopic contrast sensitivity measured with and without glare (binocular) at baseline and 6-month post-op+

    Time frame: Baseline compared to 6 month post operative visit

  5. Uncorrected Distance Visual Acuity under photopic conditions at 6-month post-op

    Time frame: Baseline compared to 6 month post operative visit

  6. Refractive predictability, percentage of eyes within ±0.25D, ±0.50D of target MRSE at 6-month post-op

    Time frame: Baseline compared to 6 month post operative visit

Other outcomes

  1. Other night vision questions and VND-Q (item 1-4, Top-2-box of each) at baseline and 6-month post-op

    Time frame: Baseline compared to 6 month post operative visit

  2. Other domain scores of PROWL-SS (glare, halo, starbursts)

    Time frame: Baseline compared to 6 month post operative visit

  3. BOSA tear film analysis at baseline and 6-month post-op

    Time frame: Baseline compared to 6 month post operative visit

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07790185
Lead sponsor
Vance Thompson Vision
Collaborators
Alcon, a Novartis Company
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Apr 20, 2026
Primary completion
Sep 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Kayla Karpuk, OD
Contact
kayla.karpuk@vancethompsonvision.com
605-361-3937

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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