A Smart Aperture Lens to Help Keratoconus and Presbyopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pre-market, interventional, open-label study comparing two lens designs: a standard refractive scleral lens and the aperture-integrated NOA lens. Researchers will assess changes in visual quality, including acuity, contrast sensitivity, and higher-order aberrations, while monitoring safety events related to the device. Participants will undergo screening, fitting, and follow-up visits with objective eye measurements and subjective vision assessments. The NOA lens is designed to enhance depth of focus and reduce aberrations, potentially informing future smart-lens concepts. The study aims to determine whether the aperture lens provides actionable benefit beyond conventional lenses for selected patients.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Koppen — University Hospital, Antwerp
• Study coordinator: Sarah Naessens
• Email: clinical@azaleavision.com
• Phone: +32498604401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.