Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus (NOA)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Lieselot Burggraeve
- 전화번호: +3292928071
- 이메일: clinical@azaleavision.com
연구 장소
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Brunssum, 네덜란드
- Visser Contactlenzen Brunssum
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연락하다:
- Korine Van Dijk, Optometrist
- 전화번호: +31 88 900 8080
- 이메일: NOAstudy@vissercontactlenzen.nl
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Antwerp, 벨기에
- University Hospital Antwerp (UZA)
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연락하다:
- Carina Koppen, Prof. Dr.
- 전화번호: +32 3 821 32 59
- 이메일: Carina.Koppen@uza.be
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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:
- 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.
- History of other known ocular pathologies that might influence the measured endpoints of the study, at the discretion of the investigator.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Keratoconus
Keratoconus, without having presbyopia
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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
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실험적: Presbyopia
Emmetropic (+-0.5 D) presbyopia, without having corneal irregularities
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mode of action NOA lens in keratoconus group
기간: As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
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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.
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As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
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Mode of action NOA lens in presbyopia group
기간: As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
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Change from baseline in near visual acuity, as measured by a logMAR chart, following a single evaluation session with the NOA lens type 2.
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As assessed at the final study visit 3 (=approximately 6 weeks after baseline) compared to the baseline visit 2 (=day 0 + approximately 6 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety of NOA lens
기간: 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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Cumulative incidence and severity of device-related safety events throughout the study, in both groups
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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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Koppen, University Hospital, Antwerp
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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