Data Collection Study in Keratoconus, Utilizing Topography and Wavefront Aberrometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Ocular Topography
研究概览
简要总结
This observational study aims to collect real-world wavefront aberrometry and corneal/scleral topography data from individuals with keratoconus and other corneal ectatic disorders. This data will be used to develop and refine a methodology for designing custom-fitted scleral contact lenses with embedded active light management technology. The study will focus on characterizing the optical imperfections (aberrations) and corneal/scleral shape variations in this population to optimize lens design for improved vision and comfort.
详细描述
Keratoconus, the most common corneal ectatic disease, and other related disorders are characterized by progressive thinning and steepening of the cornea, leading to distorted vision. This study will enroll individuals with these conditions to gather detailed information about their eyes using two non-invasive imaging techniques:
Wavefront aberrometry: Measures optical imperfections (aberrations) that contribute to visual distortions like glare, halos, and reduced visual acuity. This data will help understand the specific optical challenges faced by individuals with keratoconus and inform the development of lenses that correct these aberrations.
Ocular topography: Maps the three-dimensional shape of the cornea and sclera. The study will utilize advanced topography techniques to capture a wider scan of the ocular surface than is typically available. This expanded view is crucial for designing contact lenses that conform precisely to the irregular corneal shape in keratoconus (conformal fitting).
The primary objective of this study is to gather this crucial data to inform the development of a methodology for designing a conformal, custom-fitted contact lens. This lens, being developed by Azalea Vision, will incorporate active light management technology and is intended to address the complex visual challenges experienced by individuals with keratoconus and other corneal ectatic disorders. The data collected will enable Azalea Vision to optimize lens design for improved vision, comfort, and overall quality of life for these individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Provide written Informed Consent
- •Diagnosed with keratoconus and/or any other type of ectatic corneal disorder
- •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 for a minimum of 48 hours prior to performing the pentacam AXL Wave scan, if applicable.
- •Note: In case only 1 eye is diagnosed with keratoconus, both eyes will be scanned, as long as none of the
排除标准
- •apply to that eye
- •Exclusion Criteria:
- •Known active disease-related ocular surface problem (i.e. microbial keratitis)
- •History of ocular pathologies that might lead to incomplete/incorrect eye surface scan AND wavefront aberrometry, at the discretion of the investigator
- •Use of fluorescein in the eye, within 12 hours prior to the pentacam AXL Wave scan is performed
- •Contact lens refitting within one month prior to the pentacam AXL Wave scan, as this can significantly impact the corneal or scleral surface.
- •Currently wearing hybrid contact lenses
- •Having worn contact lenses within 48 hours prior to performing the pentacam AXL Wave scan. Note: this criteria might not be applicable yet at the time of signing ICF, but needs to be confirmed prior to performing the Pentacam AXL Wave Scan
- •Note: In case any of the above exclusion criteria are met in 1 eye, but not in the other, it's sufficient to perform the scan on the "non" affected eye.
研究组 & 干预措施
Keratoconus and corneal ectasia
wavefront aberrometry and topography measurement through Pentacam AXL Wave device
干预措施: Ocular Topography and Wavefront Aberrometry (Other)
结局指标
主要结局
Ocular Topography
时间窗: during the Eyescan procedure
Mapping of the ocular surface
Wavefront aberrometry
时间窗: during the Eyescan procedure
Quantification of the wavefront aberrations
次要结局
- Ocular Topography(during the Eyescan procedure)
- Wavefront aberrometry(during the Eyescan procedure)
- Anterior chamber depth(during the Eyescan procedure)
- Axial length(during the Eyescan procedure)
- Pupillometry(during the Eyescan procedure)
- Distribution level of keratoconus severity(during the Eyescan procedure)