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

This is a pre-market, interventional, exploratory, open-label, proof-of-concept study designed to validate the mode of action of the NOA lens, which is a freeform, rigid gas permeable (RGP) scleral contact lens customized to the unique topography of each patient's eye. The investigation serves as a functional prototype to validate the technology intended for the future ALMA Smart Lens by utilizing a specialized integrated optical aperture (pinhole) to enhance depth of focus and reduce the impact of optical aberrations.

The study primarily aims to validate this mode of action by evaluating the lens's effectiveness: for patients with keratoconus, the focus is on reducing higher-order aberrations, whereas for patients with presbyopia, the focus is on improving near visual acuity. While the primary focus is on these visual improvements, the study also evaluates the safety profile of the device by monitoring the cumulative incidence and severity of device-related safety events throughout the participation period.

The clinical process begins with a screening visit where eligibility is confirmed through medical history, visual acuity measurements, and comprehensive eye scans, including corneal topography and wavefront aberrometry. During the baseline visit, patients are fitted with the NOA lens Type 1, a scleral lens that provides standard refractive correction. After the lens has settled, investigators perform assessments of visual acuity, contrast sensitivity, visual field, and aberrometry to establish a reference standard. At the final testing visit, the process is repeated using the NOA lens Type 2, which incorporates the internally sealed optical aperture, allowing for a direct comparison of visual performance and higher-order aberrations against the baseline.

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.