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

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.

NCT Number	NCT07559188
Lead Sponsor	Azalea Vision
Conditions	Keratoconus, Presbyopia, Scleral Contact Lenses, Pinhole
Enrollment	16 participants
Start Date	2026-10-01
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-02