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

NCT07559188 | Not Yet Recruiting

• 1 other identifier: Az02
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Keratoconus; Presbyopia; Scleral Contact Lenses; Pinhole

Keywords

keratoconus; presbyopia; scleral contact lenses; pinhole; central aperture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety of NOA lens

  as from screening visit 1 (day 0) until study completion, which takes place on average 12 weeks after the screening visit.

Study Arms (2)

Keratoconus

EXPERIMENTAL

Keratoconus, without having presbyopia

Device: NOA lens type 1; Device: NOA lens type 2

Presbyopia

EXPERIMENTAL

Emmetropic (+-0.5 D) presbyopia, without having corneal irregularities

Device: NOA lens type 1; Device: NOA lens type 2

Interventions

NOA lens type 1 DEVICE

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

Keratoconus; Presbyopia

NOA lens type 2 DEVICE

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

Keratoconus; Presbyopia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azalea Vision: lead

Study Sites (2)

University Hospital Antwerp (UZA)

Antwerp, Belgium

Location

Visser Contactlenzen Brunssum

Brunssum, Netherlands

Location

MeSH Terms

Conditions

Keratoconus; Presbyopia

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Refractive Errors

Study Officials

• Koppen

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieselot Burggraeve

CONTACT

+3292928071; clinical@azaleavision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Europe, this type of study is considered interventional, as it contains study procedures being conducted outside of standard of care.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); NL (1)