No phaseRecruitingAge-related condition
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus (NOA)
- Sponsor
- Azalea Vision (Industry)
- Enrolment
- 16 planned
- Conditions
- Keratoconus; Presbyopia; Scleral Contact Lenses; Pinhole
- Interventions
- NOA lens type 1; NOA lens type 2
- Ages
- adults, older adults
- Registry
- NCT07559188
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Mode of action NOA lens in keratoconus group
- Mode of action NOA lens in presbyopia group
History
Primary completion expected
Last registry update
Started
Registered