Clinical Evaluation of WaveLight Plus LASIK

Laser Defined Vision

Status: Not yet enrolling

Conditions: Myopia; Astigmatism

Treatments: Device: Wavelight Plus LASIK

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07127757

KS-25-01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Wavelight Plus LASIK

Treatment:

Device: Wavelight Plus LASIK