Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT07127757
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 -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
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07127757
Study Brief:
Protocol Section:
NCT07127757