Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus (NOA)

Inclusion Criteria:

• Age ≥ 18y at time of informed consent.
• Provide written Informed Consent.
• Being diagnosed in both eyes with:
• Keratoconus, without having presbyopia (Group A) OR: Emmetropic (+-0.5 D) presbyopia, without having corneal irregularities (Group B)
• Cornea considered to be clinically stable at the discretion of the investigator (e.g. no recent cross linking performed, no current corneal sutures, no corneal sutures recently removed).
• Willing to remove current contact lenses (any type) in both eyes for a minimum of 48 hours prior to every study visit.
• Able to read Dutch.

Exclusion Criteria:

• Active ocular infection or inflammation, including infectious keratitis, infectious conjunctivitis or blepharitis with discharge.
• Medical history (of ocular pathologies) that might lead to incomplete/incorrect eye surface scan OR wavefront aberrometry, at the discretion of the investigator.
• Use of fluorescein in the eye, within 12 hours prior to the PentacamAXL Wave scan.
• Contact lens refitting within one month prior to the screening PentacamAXL Wave scan (or planned refitting throughout the study), as this can significantly impact the corneal or scleral surface.
• Use of hybrid contact lenses or corneal RGP contact lenses within 3 months prior to (or planned use during) study participation.
• Having worn contact lenses (any type) within 48 hours prior to performing the screening Pentacam AXL Wave scan at visit 1.
• Clinically significant acute non-infectious ocular surface abnormality, including active corneal abrasion, recent ocular surface trauma.
• Severe ocular surface disease that prevents safe lens application, stable wear, or lens removal.
• Severe corneal hypoesthesia or neurotrophic keratopathy which would impair perception of pain, foreign body sensation or delay symptom reporting.
• Known hypersensitivity or allergy to the lens material or approved cleaning, disinfecting or filling solutions.
• Active allergic eye disease, including active papillary or follicular conjunctivitis.
• Systemic conditions known to impair corneal healing, such as uncontrolled autoimmune disease.
• Glaucoma.
• Central opacity and/or central corneal scarring and/or cataract.
• History of low corneal endothelial cell count (< 1500 cells/mm2) or endothelial pathologies, at the discretion of the investigator.
• Aphakic and pseudophakic.
• Severe meibomian gland dysfunction, at the discretion of the investigator.
• Known vitreoretinal pathologies, at the discretion of the investigator.
• Subjects needing eye drops every 2hrs.
• Pregnant or breastfeeding woman.
• History of other known ocular pathologies that might influence the measured endpoints of the study, at the discretion of the investigator.