Recruiting

WaveLight® Plus

Sponsor:

Vance Thompson Vision

Code:

NCT07790185

Conditions

Astigmatism

Myopia

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Wavelight Plus

Study Details

Brief summary:

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

Conditions

Astigmatism

Myopia

Study ID

NCT07790185

Start date

Apr 20, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: WaveLight Plus

Interventions

Wavelight Plus

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

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Locations

Vance Thompson Vision

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

More Information

Sponsor

Vance Thompson Vision

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vance Thompson Vision on 2026-08-27.