Clinical trial NCT06859398: KeratoConus Data Acquisition With Topography and Aberrometry
Official title: Data Collection Study in Keratoconus, Utilizing Topography and Wavefront Aberrometry
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Corneal Ectasia
Keratoconus
Keywords: Keratoconus
Corneal ectasia
Wavefront aberrometry
Corneal topography
Scleral topography
Ocular topography
Irregular corneal condition
Lead sponsor: Azalea Vision
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is considered as a data collection study. As the data which will be collected within this study, is not collected per standard of care, the study is considered interventional in the participating countries.
Primary purpose: OTHER

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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Ocular Topography
timeFrame: during the Eyescan procedure
measure: Wavefront aberrometry
timeFrame: during the Eyescan procedure
Secondary outcomes:
measure: Ocular Topography
timeFrame: during the Eyescan procedure
measure: Ocular Topography
timeFrame: during the Eyescan procedure
measure: Ocular Topography
timeFrame: during the Eyescan procedure
measure: Wavefront aberrometry
timeFrame: during the Eyescan procedure
measure: Anterior chamber depth
timeFrame: during the Eyescan procedure
measure: Axial length
timeFrame: during the Eyescan procedure
measure: Pupillometry
timeFrame: during the Eyescan procedure
measure: Distribution level of keratoconus severity
timeFrame: during the Eyescan procedure
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp (UZA)
Study officials:
affiliation: University Hospital, Antwerp
name: Carina Koppen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: