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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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
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
University Hospital Antwerp (UZA)
Antwerp, Belgium
Visser Contactlenzen Brunssum
Brunssum, Netherlands
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.
Time frame: 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.
Time frame: As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
Safety of NOA lens
Cumulative incidence and severity of device-related safety events throughout the study, in both groups
Time frame: as from screening visit 1 (day 0) until study completion, which takes place on average 12 weeks after the screening visit.
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