Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Sponsor: Azalea Vision • ClinicalTrials.gov ID: NCT07559188
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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.
Interventions
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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
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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
Eligibility criteria
Conditions
Locations
- University Hospital Antwerp (UZA) — Antwerp, Belgium
- Visser Contactlenzen Brunssum — Brunssum, Netherlands
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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