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.
Eligibility
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