Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear

Clinical Evaluation of Safety and Effectiveness for Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear

The objective of this clinical investigation is to collect scientifically valid safety and effectiveness data on the Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear. The clinical performance data reported from this study is intended to be submitted to the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a new Premarket Application (PMA).

Orthokeratology is an alternative method to correct refractive errors using individually designed gas permeable (rigid) lenses worn overnight to temporarily modify the curvature of cornea. Modern orthokeratology technology uses highly permeable rigid lens material and dynamic reverse geometry designs to allow faster and more effective corneal reshaping. Acuity 200™ (fluoroxyfocon A) is a stable material with relatively higher oxygen permeability compared to other marketed gas permeable materials. The clinical effects of wearing contact lenses that limit oxygen supply have been extensively reported with potential complications related to hypoxia including corneal swelling, epithelial microcysts, limbal hyperemia, corneal vascularization, refractive error changes and corneal distortion. Given the significantly higher oxygen permeability characteristics of Acuity 200™ (fluoroxyfocon A) relative to currently FDA approved orthokeratology materials, the material is well-suited for overnight wear applications-such as orthokeratology, when the eye is subject to hypoxic conditions during sleep.

The objective of the clinical investigation (AVDR 2022-01) is to collect scientifically valid safety and effectiveness data on the Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear. The clinical performance data reported from the study is intended to be submitted to the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a new Premarket Application (PMA). The hypothesis is that the primary and secondary outcomes for safety and effectiveness are consistent with currently marketed devices approved by the FDA for overnight orthokeratology.

Inclusion Criteria:

1. Is age 7 or older with full legal capacity to volunteer or has parental or legal guardian written approval to volunteer; and has read, understood and signed the Informed Consent Form or Assent Form (for subjects 18 years and under);
2. Is willing and able to follow participant instructions for product usage and meet the specified schedule of follow-up visits;
3. Has naturally occurring refractive myopia from -0.75 to -6.00 diopters sphere (spectacle plane), with refractive astigmatism (spectacle plane) up to 1.75 DC-as determined by adjusted manifest refraction (phoropter or trial frame) with a 12.5 mm vertex distance.
4. Has a best spectacle corrected visual acuity of 0.04 log MAR (20/20 -2) or better in each eye;
5. Is free of eye disease and binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) that may affect vision or contact lens wear; Has normal healthy eyes with no evidence of lid infection or structural abnormality; a conjunctiva free of infection; a cornea clear and free of edema, visually or topographically significant scars, clinically significant staining, significant vascularization, infiltrates when examined by slit-lamp biomicroscopy; and no evidence of iritis or uveitis.

Exclusion Criteria:

1. Is pregnant, breast-feeding or intends to become pregnant over the course of the study.
2. Is a potential pediatric subject that does not have the appropriate level of psychological maturity to comply with appropriate procedures needed for safe wear according to the investigator.
3. Is a potential pediatric subject that is a ward of the State or any other agency, institution, or entity.
4. Has a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis. NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, specifically excludes subjects from eligibility.
5. Has a history of intraocular or corneal surgery (including cataract extraction and refractive surgery-such as Lasik), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or with evidence of glaucoma or propensity for narrow angle glaucoma as determined by gonioscopic examination in either eye. NOTE: This includes any subject with open angle glaucoma, regardless of medication regimen or control. Additionally, any subject with an IOP greater than 21 mm Hg at baseline is specifically excluded from eligibility.
6. Has evidence of keratoconus, corneal irregularity, or abnormal video-keratography in either eye.
7. Has a pupil size greater than 6.0 mm in photopic illumination as measured with pupil detection component of computer assisted video keratography.
8. Has a corneal diameter of 10 mm or less;
9. Has flat keratometry values flatter than 38.00D (8.88 mm), or steeper than 47.00D (7.16 mm);
10. Takes medication that may cause dry eye or affect vision, corneal curvature, or healing (i.e., corticosteroids);
11. Has an allergy to any ingredient in the study lens care solutions;
12. Has significant ocular allergy, which would contraindicate solution use and/or "normal" contact lens wear;
13. Is currently using or has a history of atropine use for myopia progression control
14. Is a current wearer or previous wearer within the last 90 days of daily wear rigid gas permeable contact lenses, extended wear rigid gas permeable contact lenses, or orthokeratology contact lenses;
15. Is participating in any other type of clinical or research study.