WaveLight Plus LASIK for nearsightedness and astigmatism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site, single-arm, prospective observational study of adults undergoing bilateral WaveLight Plus LASIK. Participants will have pre- and post-operative clinical evaluations including refractive outcomes, visual acuity, and patient-reported outcome questionnaires (adapted PROWL and LLQ-32), with follow-up up to three months after surgery. Eligible subjects must be 18 or older with myopia up to −8.00 D and astigmatism up to −3.00 D, stable refraction, best-corrected visual acuity of 20/20-2 or better, and mesopic pupil size ≥ 4.5 mm. The study aims to characterize patient satisfaction, quality of vision, and quality of life after the procedure rather than compare treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Laser Defined Vision
  Greensboro, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Karl Stonecipher, MD — Laser Defined Vision
• Study coordinator: Carrie Williams
• Email: ldv2020@gmail.com
• Phone: 336-288-8823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.