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

Starting soon · Not applicable

Conditions studied: Keratoconus, Presbyopia, Scleral Contact Lenses, Pinhole

In brief

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.

Key facts

Study ID

NCT07559188

Run by

Azalea Vision

People needed

16

Starts

2026-10-01

Expected to finish

2027-03-31

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospital Antwerp (UZA) — Antwerp, Belgium
• Visser Contactlenzen Brunssum — Brunssum, Netherlands

Full record on ClinicalTrials.gov

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