[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pinhole\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pinhole":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100635938","proof-of-concept-for-a-novel-optical-aperture-contact-lens-in-presbyopia-and-keratoconus-100635938",false,"NCT07559188","Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus","NOA","Inclusion Criteria:\n\n* Age ≥ 18y at time of informed consent.\n* Provide written Informed Consent.\n* Being diagnosed in both eyes with:\n* Keratoconus, without having presbyopia (Group A) OR: Emmetropic (+-0.5 D) presbyopia, without having corneal irregularities (Group B)\n* 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).\n* Willing to remove current contact lenses (any type) in both eyes for a minimum of 48 hours prior to every study visit.\n* Able to read Dutch.\n\nExclusion Criteria:\n\n* Active ocular infection or inflammation, including infectious keratitis, infectious conjunctivitis or blepharitis with discharge.\n* Medical history (of ocular pathologies) that might lead to incomplete\u002Fincorrect eye surface scan OR wavefront aberrometry, at the discretion of the investigator.\n* Use of fluorescein in the eye, within 12 hours prior to the PentacamAXL Wave scan.\n* 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.\n* Use of hybrid contact lenses or corneal RGP contact lenses within 3 months prior to (or planned use during) study participation.\n* Having worn contact lenses (any type) within 48 hours prior to performing the screening Pentacam AXL Wave scan at visit 1.\n* Clinically significant acute non-infectious ocular surface abnormality, including active corneal abrasion, recent ocular surface trauma.\n* Severe ocular surface disease that prevents safe lens application, stable wear, or lens removal.\n* Severe corneal hypoesthesia or neurotrophic keratopathy which would impair perception of pain, foreign body sensation or delay symptom reporting.\n* Known hypersensitivity or allergy to the lens material or approved cleaning, disinfecting or filling solutions.\n* Active allergic eye disease, including active papillary or follicular conjunctivitis.\n* Systemic conditions known to impair corneal healing, such as uncontrolled autoimmune disease.\n* Glaucoma.\n* Central opacity and\u002For central corneal scarring and\u002For cataract.\n* History of low corneal endothelial cell count (\\\u003C 1500 cells\u002Fmm2) or endothelial pathologies, at the discretion of the investigator.\n* Aphakic and pseudophakic.\n* Severe meibomian gland dysfunction, at the discretion of the investigator.\n* Known vitreoretinal pathologies, at the discretion of the investigator.\n* Subjects needing eye drops every 2hrs.\n* Pregnant or breastfeeding woman.\n* History of other known ocular pathologies that might influence the measured endpoints of the study, at the discretion of the investigator.","ALL","18 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.\n\nThis 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.\n\nThe 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.",[26,27,28,29],"Keratoconus","Presbyopia","Scleral Contact Lenses","Pinhole",[31,32,33,34,35],"keratoconus","presbyopia","scleral contact lenses","pinhole","central aperture","NOT_YET_RECRUITING","2026-07-01",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":20},"2026-10-01",{"date":44,"type":20},"2027-03-31",{"name":46,"class":47},"Azalea Vision","INDUSTRY",2]