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

The purpose of this clinical study is to evaluate the effectiveness of the NOA lens, a custom-made scleral contact lens developed by Azalea Vision BV, in improving visual quality for individuals with keratoconus and presbyopia. This clinical study investigates a new lens design featuring a specific central aperture (opening) intended to enhance image quality by increasing depth of focus and reducing optical aberrations. The NOA lens serves as a functional prototype for future "smart lens" technology, specifically the ALMA Smart Lens. The study aims to determine if this specialized lens provides a solution for patients whose visual needs are not fully met by conventional glasses or contact lenses. The investigation will compare a standard refractive scleral lens (Type 1) against the aperture-integrated lens (Type 2) to validate the "pinhole effect" in improving vision and reducing higher-order aberrations.

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.