Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzalea Vision
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18y at time of informed consent.
Provide written Informed Consent.
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).
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
NOA lens type 1
DeviceProvides 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
NOA lens type 2
DeviceIncorporates 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
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: KeratoconusExperimental treatment 2 interventions
Group B: PresbyopiaExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov