keratoconus, ectatic corneal disorder - presbiopia, age-related farsightedness corneal disorder - age-related farsightedness
Conditions
Interventions
The device under investigation is the NOA lens, a scleral rigid gas permeable (RGP) contact lens. The legal manufacturer is Azalea Vision BV. The NOA lens features a freeform design that is customized
or Presbyopia 
The investigational device is a freeform (conformal fitting) large scleral RGP contact lens. It is manufactured from two RGP components (Part A and Part B) that are precision lathe-cut and bonded toge
 
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.The dimensional characte
the only difference is the presence of the internally sealed optical aperture.
Sponsors
Azalea Vision
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age = 18y at time of informed consent.Provide written Informed Consent.Being diagnosed in both eyes with: 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).Willing to remove current contact lenses (any type) in both eyes for a minimum of 48 hours prior to every study visit. Able to read Dutch.
Exclusion criteria
Exclusion criteria: 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. Use of hybrid contact lenses or corneal RGP contact lenses within 3 months prior to (or planned use during) study participation.Having worn contact lenses (any type) within 48 hours prior to performing the screening Pentacam AXL Wave scan at visit 1.Clinically significant acute non-infectious ocular surface abnormality, including active corneal abrasion, recent ocular surface trauma.Severe ocular surface disease that prevents safe lens application, stable wear, or lens removal.Severe corneal hypoesthesia or neurotrophic keratopathy which would impair perception of pain, foreign body sensation or delay symptom reporting.Known hypersensitivity or allergy to the lens material or approved cleaning, disinfecting or filling solutions.Active allergic eye disease, including active papillary or follicular conjunctivitis.Systemic conditions known to impair corneal healing, such as uncontrolled autoimmune disease.Glaucoma.Central opacity and/or central corneal scarring and/or cataract.History of low corneal endothelial cell count (< 1500 cells/mm2) or endothelial pathologies, at the discretion of the investigator.Aphakic and pseudophakic.Severe meibomian gland dysfunction, at the discretion of the investigator. Known vitreoretinal pathologies, at the discretion of the investigator.Subjects needing eye drops every 2hrs.Pregnant or breastfeeding woman.21. History of other known ocular pathologies that might influence the measured endpoints of the study, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is Group A (Keratoconus)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.Group B (Presbyopia)Change from baseline in near visual acuity, as measured by a logMAR chart, following a single evaluation session with the NOA lens type 2 after the lens has settled. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint of this study is: Cumulative incidence and severity of device-related safety events throughout the study (Groups A and B). | — |
Countries
Belgium, Netherlands
Contacts
Public ContactSN Naessens
Junipr Research
Outcome results
None listed