Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzalea Vision
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18y at time of informed consent.
Provide written Informed Consent.
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- NOA lens type 1
- NOA lens type 2
Treatment groups
16 Participants
are divided into 2 treatment groupsLocations
2Belgium
University Hospital Antwerp (UZA) Antwerp Belgium
Netherlands
Visser Contactlenzen Brunssum Brunssum Netherlands
Sponsors and collaborators
Azalea Vision
Lead sponsor
Source ClinicalTrials.gov