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Clinical Evaluation of WaveLight Plus LASIK

RecruitingObservational study

Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Subject must be able to understand and sign an IRB approved Informed consent form
* Willing and able to attend all scheduled study visits as required per protocol
* Minimum of 18 years of age
* Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction
* Best corrected photopic distance visual acuity of 20/20-2 or better (≤ 0.04 logMAR)
* Mesopic pupil size ≥ 4.5mm
* Less than 0.75 D manifest refraction spherical equivalent difference between Sightmap refraction and subjective manifest refraction
* Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery, verified by consecutive subjective refractions or medical records or prescription history
* If currently wearing contact lenses:

  * Soft CTL wearers discontinue for minimum 3 days prior to first refraction
  * RGP or toric soft CTL wearers discontinue for ≥2 weeks prior to first refraction

Exclusion Criteria:

* Subjects who are pregnant or nursing
* Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study
* Patients with flap complications
* Systemic medications that may confound the outcome of the study or increase the risk to the subject.
* Ocular condition (other than high myopia) that may predispose the subject to future complications, such as ectasia
* History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy)
* Evidence of retinal vascular disease
* Keratoconus or Keratoconus suspect
* Glaucoma or glaucoma suspect by exam findings and/or family history
* Previous intraocular or corneal surgery
* Predicted residual stromal bed thickness \< 250 μm
* Intended to have monovision treatment
* Participation in other current clinical trials

About the study

This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL and Low Luminance Questionnaire (LLQ-32) Questionnaire.

What is being tested

Sponsor: Laser Defined Vision · Participants: 50 · Started: Aug 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07127757

Locations in the U.S.

North CarolinaLaser Defined Vision, Greensboro

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.