Clinical Evaluation of WaveLight Plus LASIK
Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting
Laser Defined Vision
50 participants
Aug 28, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria13
- 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
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Interventions
Wavelight plus LASIK is an advanced laser eye surgery technology designed to enhance visual outcomes through personalized treatment plans. This system integrates comprehensive diagnostics, including biometry, tomography, and wavefront measurements, to create a tailored ablation profile for each patient.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07127757