KeratoconusNOANCT07559188
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
A study testing NOA lens type 1 and NOA lens type 2 in people with Keratoconus and Presbyopia, run by Azalea Vision at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus, Presbyopia, Scleral Contact Lenses
- What is being tested?
- NOA lens type 1 and NOA lens type 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Sep 2026to 31 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp (UZA)
Antwerp
Carina Koppen, Prof. Dr., +32 3 821 32 59, Carina.Koppen@uza.be
Netherlands1 site, 1 recruiting
- Recruiting
Visser Contactlenzen Brunssum
Brunssum
Korine Van Dijk, Optometrist, +31 88 900 8080, NOAstudy@vissercontactlenzen.nl
About this study
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.
Read the detailed description
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.
- Conditions
- Keratoconus, Presbyopia, Scleral Contact Lenses, Pinhole
- Being tested
- NOA lens type 1, NOA lens type 2
- Keywords
- keratoconus, presbyopia, scleral contact lenses, pinhole, central aperture
- Medical subject headings
- Keratoconus, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOA lens type 1Device
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
NOA lens type 2Device
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
| Study group | Role | What they receive |
|---|---|---|
| Keratoconus | Experimental | Keratoconus, without having presbyopia Receives: Device: NOA lens type 1; Device: NOA lens type 2 |
| Presbyopia | Experimental | Emmetropic (+-0.5 D) presbyopia, without having corneal irregularities Receives: Device: NOA lens type 1; Device: NOA lens type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of action NOA lens in keratoconus group
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.
Measured: 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
Change from baseline in near visual acuity, as measured by a logMAR chart, following a single evaluation session with the NOA lens type 2.
Measured: As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
Secondary outcomes (1)
Safety of NOA lens
Cumulative incidence and severity of device-related safety events throughout the study, in both groups
Measured: as from screening visit 1 (day 0) until study completion, which takes place on average 12 weeks after the screening visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start28 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In Europe, this type of study is considered interventional, as it contains study procedures being conducted outside of standard of care.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azalea Vision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koppen, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559188
- Sponsor's protocol ID
- Az02
- Acronym
- NOA
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.