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Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
Full description
A randomized evaluation of clinical outcomes following bilateral implantation of EVO+ Visian™ Implantable Collamer™ Lenses or bilateral Wavefront-optimized LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
Enrollment
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Inclusion criteria
Preoperatively the Investigator will evaluate each study subject and refer to the directions for use for EVO+ ICL and Wavefront-Optimized LASIK to confirm the subject's suitability to proceed with bilateral EVO+ ICL Implantation or bilateral Wavefront-optimized LASIK in accordance with the Investigator's standard of care for each procedure. To ensure similar characteristics across study subjects, the Investigator will also adhere to the following criteria for each group:
Exclusion criteria
Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator.
Serious acute, chronic, or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, uncontrolled diabetes, etc.), in the opinion of the Investigator.
Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator. For example:
Pigment dispersion,
History or clinical signs of iritis/uveitis,
History of previous ocular surgery,
Monocular subjects,
History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.),
Evidence of retinal vascular disease,
Keratoconus or keratoconus suspect,
Glaucoma or glaucoma suspect by exam findings,
Ocular surface disease other than controlled dry eye syndrome. 5. Subjects who do not qualify for both study arms:
Bilateral Wavefront Optimized LASIK
Bilateral EVO+ ICL implantation
Subjects who, in the judgment of the Investigator, present any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
Participation in another clinical trial involving ocular procedures within the last 6-months.
Other conditions or assessment that causes the subject to not be an acceptable candidate for treatment or study participation as clinically assessed and documented by the Investigator.
Primary purpose
Allocation
Interventional model
Masking
56 participants in 2 patient groups
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Central trial contact
Tiffany R Facile, MBA, MHA, BS, RN
Data sourced from clinicaltrials.gov
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