Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Mode of action NOA lens in keratoconus group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
- •History of other known ocular pathologies that might influence the measured endpoints of the study, at the discretion of the investigator.
结局指标
主要结局
Mode of action NOA lens in keratoconus group
时间窗: As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
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.
Mode of action NOA lens in presbyopia group
时间窗: As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
Change from baseline in near visual acuity, as measured by a logMAR chart, following a single evaluation session with the NOA lens type 2.
次要结局
- Safety of NOA lens(as from screening visit 1 (day 0) until study completion, which takes place on average 12 weeks after the screening visit.)