💬In plain words
What the trial is, and whether it could suit you
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 highe
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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