AstigmatismPhase 4NCT07790185
Evaluation of Mesopic Visual Acuity and Patient Satisfaction Following Ray-Tracing-Guided LASIK
A Phase 4 study testing Wavelight Plus in people with Astigmatism and Myopia, run by Vance Thompson Vision at 1 site in United States.
Trial summary
To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Astigmatism, Myopia
- What is being tested?
- Wavelight Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to Nov 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects ages 18 to 45 years old.
- 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.
- 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)
- Best corrected distance visual acuity (BCDVA) of 20/20 or better (≥83 letters) in each eye.
- Subjects who have elected to undergo bilateral LASIK targeted for emmetropia.
- Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
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- 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.
- Mesopic pupil size ≥4.5mm
- Less than 0.75D spherical equivalent differences between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)
- Subjects who regularly drive at night and expect to continue night driving throughout the duration of the study, as determined by investigator assessment
Who cannot join
- 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.
- 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.
- Previous corneal ocular surgery
- History of evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma or glaucoma suspect.
- 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.
- Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator.
- 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.
- Patients with a calculated residual stromal depth <250 um
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Kayla Karpuk, OD, 605-361-3937, kayla.karpuk@vancethompsonvision.com
About this study
To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
- Conditions
- Astigmatism, Myopia
- Being tested
- Wavelight Plus
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavelight PlusDevice
comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
| Study group | Role | What they receive |
|---|---|---|
| WaveLight Plus | Experimental | Not described Receives: Device: Wavelight Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline compared to 6 month post operative visit
Secondary outcomes (6)
Satisfaction with night vision (modified based on #1 of PROWL-SS, 0 - 100) at baseline and 6-month post-op
Measured: Baseline compared to 6 month post operative visit
Difficulty driving at night (from PROWL, Top-2-box) at baseline and 6-month post-op
Measured: 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
Measured: Baseline compared to 6 month post operative visit
Mesopic contrast sensitivity measured with and without glare (binocular) at baseline and 6-month post-op+
Measured: Baseline compared to 6 month post operative visit
Uncorrected Distance Visual Acuity under photopic conditions at 6-month post-op
Measured: 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
Measured: Baseline compared to 6 month post operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start20 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon, a Novartis Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790185
- Sponsor's protocol ID
- 101390595
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes