No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Laser Defined Vision · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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…
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
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