Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keratoconus and corneal ectasia | Other | wavefront aberrometry and topography measurement through Pentacam AXL Wave device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocular Topography and Wavefront Aberrometry | Other | Eyescan with Pentacam AXL Wave |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Topography | Mapping of the ocular surface | during the Eyescan procedure |
| Wavefront aberrometry | Quantification of the wavefront aberrations | during the Eyescan procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Topography | Description of the percentage of ocular surface mapped during topography measurement | during the Eyescan procedure |
| Ocular Topography | Repeatability of topography measurements between different scans will be assessed |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Koppen, Prof. Dr. | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp (UZA) | Edegem | 2650 | Belgium | |||
| Visser Contactlenzen Brunssum |
This study will be registered in a public trial register (clinicaltrials.gov) prior to inclusion of the first subject. The content - including the participating Principal Investigators and Clinical Study Sites - will be updated throughout the conduct of the study. Results information from this study will be submitted to the public trial register.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| during the Eyescan procedure |
| Ocular Topography | Quality of topography measurements based on full sequence quality specification, using the parameters embedded in the Oculus Pentacam AXL Wave | during the Eyescan procedure |
| Wavefront aberrometry | Quality of aberrometric measurements based on full sequence quality specification embedded in the Oculus Pentacam AXL Wave | during the Eyescan procedure |
| Anterior chamber depth | as measured by the Pentacam AXL Wave. | during the Eyescan procedure |
| Axial length | as measured by the Pentacam AXL Wave | during the Eyescan procedure |
| Pupillometry | measurement of pupil size during aberrometry measurement | during the Eyescan procedure |
| Distribution level of keratoconus severity | using the parameters embedded in the Oculus Pentacam AXL Wave | during the Eyescan procedure |
| Brunssum |
| 6443 |
| Netherlands |