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Recruiting NCT07127757

Clinical Evaluation of WaveLight Plus LASIK

— Observational Myopia Astigmatism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wavelight Plus LASIK.
Who it may be relevant to
Registry conditions: Myopia, Astigmatism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Wavelight Plus LASIK
    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.

Primary outcome measures

  • % of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular) [Time frame: 3 months postoperatively]
  • % of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in mesopic conditions at 3 months (monocular and binocular) [Time frame: 3 months postoperatively]
  • % of eyes with CDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular) [Time frame: 3 months postoperatively]
Secondary outcome measures (5)
  • % of eyes that achieve UDVA equal to or better than preoperative CDVA [Time frame: 3 months postoperatively]
  • % of eyes with lines gained/lost lines (post-up UDVA VS pre-op CDVA) [Time frame: 3 months postoperatively]
  • % of eyes with absolute MRSE within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months [Time frame: 3 months postoperatively]
  • % of eyes that achieved manifest refraction cylinder within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months [Time frame: 3 months postoperatively]
  • Patient-Reported Outcomes with the modified PROWL Questionnaire and Low Luminance Questionnaire (LLQ-32) at 3 months [Time frame: 3 months postoperatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Laser Defined Vision — Greensboro

Identifiers

NCT: NCT07127757 · KS-25-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗