WaveLight Plus LASIK for nearsightedness and astigmatism
Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting
This study will try WaveLight Plus LASIK in adults with nearsightedness and astigmatism to see if it improves vision, satisfaction, and quality of life over three months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laser Defined Vision Academic / other |
| Locations | 1 site (Greensboro, North Carolina) |
| Trial ID | NCT07127757 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with myopia up to −8.00 D and astigmatism up to −3.00 D, stable refraction for at least 12 months, best-corrected visual acuity of 20/20-2 or better, mesopic pupil ≥4.5 mm, and ability to attend follow-up visits are ideal candidates.
Not a fit: People with refractive errors outside the specified ranges, unstable or progressive prescriptions, significant corneal disease or irregularities, or other ocular conditions that limit visual potential are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, participants could experience improved uncorrected vision and higher satisfaction with daily visual tasks, potentially reducing dependence on glasses or contacts.
How similar studies have performed: LASIK with the WaveLight platform and other modern excimer/laser systems has extensive evidence showing good refractive accuracy and high patient satisfaction, so this approach aligns with prior successful reports.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Greensboro, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.