Corneal Ectasia, Keratoconus
Conditions
Keywords
Keratoconus, Corneal ectasia, Wavefront aberrometry, Corneal topography, Scleral topography, Ocular topography, Irregular corneal condition
Brief summary
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.
Detailed description
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.
Interventions
OTHEROcular Topography and Wavefront Aberrometry
Eyescan with Pentacam AXL Wave
Sponsors
Azalea Vision
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This study is considered as a data collection study. The data which will be collected within this study, is not collected per standard of care. Depending on the participating country, the study is considered interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
apply to that eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Topography | during the Eyescan procedure | Mapping of the ocular surface |
| Wavefront aberrometry | during the Eyescan procedure | Quantification of the wavefront aberrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterior chamber depth | during the Eyescan procedure | as measured by the Pentacam AXL Wave. |
| Axial length | during the Eyescan procedure | as measured by the Pentacam AXL Wave |
| Ocular Topography | during the Eyescan procedure | Description of the percentage of ocular surface mapped during topography measurement |
| Distribution level of keratoconus severity | during the Eyescan procedure | using the parameters embedded in the Oculus Pentacam AXL Wave |
| Pupillometry | during the Eyescan procedure | measurement of pupil size during aberrometry measurement |
| Wavefront aberrometry | during the Eyescan procedure | Quality of aberrometric measurements based on full sequence quality specification embedded in the Oculus Pentacam AXL Wave |
Countries
Belgium, Netherlands
Outcome results
None listed