KeratoConus Data Acquisition With Topography and Aberrometry

Not Applicable

Not yet recruiting

• Conditions: Corneal Ectasia; Keratoconus

• Registration Number: NCT06859398
• Lead Sponsor: Azalea Vision

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.

Study Timeline

• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Study Start: 2025-05-15
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ocular Topography	during the Eyescan procedure	Mapping of the ocular surface
Wavefront aberrometry	during the Eyescan procedure	Quantification of the wavefront aberrations

Secondary Outcome Measures

Name	Time	Method
Ocular Topography	during the Eyescan procedure	Quality of topography measurements based on full sequence quality specification, using the parameters embedded in the Oculus Pentacam AXL Wave
Wavefront aberrometry	during the Eyescan procedure	Quality of aberrometric measurements based on full sequence quality specification embedded in the Oculus Pentacam AXL Wave
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
Pupillometry	during the Eyescan procedure	measurement of pupil size during aberrometry measurement
Distribution level of keratoconus severity	during the Eyescan procedure	using the parameters embedded in the Oculus Pentacam AXL Wave

Trial Locations

Locations (1)

University Hospital Antwerp (UZA); 🇧🇪 Edegem, Belgium