Contact lens with a small central opening for keratoconus and presbyopia

Who can take part

• 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

Who cannot take part

• 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
• Active ocular infection or inflammation, including infectious keratitis, infectious conjunctivitis or blepharitis with discharge
• Severe ocular surface disease that prevents safe lens application, stable wear, or lens removal
• 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
• History of other known ocular pathologies that might influence the measured endpoints of the study, at the discretion of the investigator
• History of low corneal endothelial cell count (< 1500 cells/mm2) or endothelial pathologies, at the discretion of the investigator
• Medical history (of ocular pathologies) that might lead to incomplete/incorrect eye surface scan OR wavefront aberrometry, at the discretion of the investigator
• Clinically significant acute non-infectious ocular surface abnormality, including active corneal abrasion, recent ocular surface trauma
• Severe corneal hypoesthesia or neurotrophic keratopathy which would impair perception of pain, foreign body sensation or delay symptom reporting
• Glaucoma
• Central opacity and/or central corneal scarring and/or cataract
• 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