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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Presbyopia; Keratoconus; Pinhole; Scleral Contact Lenses
• Intervention / Treatment: Device: NOA lens type 1; Device: NOA lens type 2

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lieselot Burggraeve; Phone Number: +3292928071; Email: clinical@azaleavision.com

Study Locations

• Belgium
  • Antwerp, Belgium
    • University Hospital Antwerp (UZA)
    • Contact: Carina Koppen, Prof. Dr.; Phone Number: +32 3 821 32 59; Email: Carina.Koppen@uza.be
• Netherlands
  • Brunssum, Netherlands
    • Visser Contactlenzen Brunssum
    • Contact: Korine Van Dijk, Optometrist; Phone Number: +31 88 900 8080; Email: NOAstudy@vissercontactlenzen.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Keratoconus; Keratoconus, without having presbyopia	Device: 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; Device: 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
Experimental: Presbyopia; Emmetropic (+-0.5 D) presbyopia, without having corneal irregularities	Device: 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; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of NOA lens	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.

Collaborators and Investigators

• Sponsor: Azalea Vision
• Investigators: Principal Investigator: Koppen, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: presbyopia; keratoconus; scleral contact lenses; pinhole; central aperture
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Corneal Diseases; Presbyopia; Keratoconus
• Other Study ID Numbers: Az02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No