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

1. juli 2026 oppdatert av: Azalea Vision

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a pre-market, interventional, exploratory, open-label, proof-of-concept study designed to validate the mode of action of the NOA lens, which is a freeform, rigid gas permeable (RGP) scleral contact lens customized to the unique topography of each patient's eye. The investigation serves as a functional prototype to validate the technology intended for the future ALMA Smart Lens by utilizing a specialized integrated optical aperture (pinhole) to enhance depth of focus and reduce the impact of optical aberrations.

The study primarily aims to validate this mode of action by evaluating the lens's effectiveness: for patients with keratoconus, the focus is on reducing higher-order aberrations, whereas for patients with presbyopia, the focus is on improving near visual acuity. While the primary focus is on these visual improvements, the study also evaluates the safety profile of the device by monitoring the cumulative incidence and severity of device-related safety events throughout the participation period.

The clinical process begins with a screening visit where eligibility is confirmed through medical history, visual acuity measurements, and comprehensive eye scans, including corneal topography and wavefront aberrometry. During the baseline visit, patients are fitted with the NOA lens Type 1, a scleral lens that provides standard refractive correction. After the lens has settled, investigators perform assessments of visual acuity, contrast sensitivity, visual field, and aberrometry to establish a reference standard. At the final testing visit, the process is repeated using the NOA lens Type 2, which incorporates the internally sealed optical aperture, allowing for a direct comparison of visual performance and higher-order aberrations against the baseline.

Studietype

Intervensjonell

Registrering (Antatt)

16

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Belgia
      • Antwerp, Belgia
        • University Hospital Antwerp (UZA)
        • Ta kontakt med:
  • Nederland
      • Brunssum, Nederland

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Keratoconus
Keratoconus, without having presbyopia
Enhet: NOA lens type 1
Provides standard refractive correction. It is a clear (un-printed) lens used only to design the type 2 lens by assessing on-eye centration and stability. It also acts as the reference standard for baseline assessments in the NOA study
Enhet: NOA lens type 2
Incorporates an integrated optical aperture (pinhole) created by an opaque dye, in addition to standard refractive correction. This opaque layer is printed on an internal surface and sealed within the lens cavity. The inclusion of this optical aperture is intended to enhance depth of focus (the "pinhole effect") and reduce the impact of optical aberrations
Eksperimentell: Presbyopia
Emmetropic (+-0.5 D) presbyopia, without having corneal irregularities
Enhet: NOA lens type 1
Provides standard refractive correction. It is a clear (un-printed) lens used only to design the type 2 lens by assessing on-eye centration and stability. It also acts as the reference standard for baseline assessments in the NOA study
Enhet: NOA lens type 2
Incorporates an integrated optical aperture (pinhole) created by an opaque dye, in addition to standard refractive correction. This opaque layer is printed on an internal surface and sealed within the lens cavity. The inclusion of this optical aperture is intended to enhance depth of focus (the "pinhole effect") and reduce the impact of optical aberrations

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mode of action NOA lens in keratoconus group
Tidsramme: As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
Change from baseline in higher-order aberrations (HOAs), as measured by a wavefront aberrometer and expressed as the total root mean square (RMS) wavefront error, following a single evaluation session with the NOA lens type 2.
As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
Mode of action NOA lens in presbyopia group
Tidsramme: As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
Change from baseline in near visual acuity, as measured by a logMAR chart, following a single evaluation session with the NOA lens type 2.
As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety of NOA lens
Tidsramme: as from screening visit 1 (day 0) until study completion, which takes place on average 12 weeks after the screening visit.
Cumulative incidence and severity of device-related safety events throughout the study, in both groups
as from screening visit 1 (day 0) until study completion, which takes place on average 12 weeks after the screening visit.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Azalea Vision

Etterforskere

  • Hovedetterforsker: Koppen, University Hospital, Antwerp

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. mars 2027

Studiet fullført (Antatt)

31. mars 2027

Datoer for studieregistrering

Først innsendt

2. februar 2026

Først innsendt som oppfylte QC-kriteriene

23. april 2026

Først lagt ut (Faktiske)

30. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Az02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

This study will be registered in a public trial register (clinicaltrials.gov) prior to inclusion of the first subject. The content - including the participating Principal Investigators and Clinical Study Sites - will be updated throughout the conduct of the study. Results information from this study will be submitted to the public trial register.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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