KeratoConus Data Acquisition With Topography and Aberrometry

Launched by AZALEA VISION · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how to better design custom contact lenses for people with keratoconus and other similar eye conditions. Researchers want to collect information about the shape of the eye and any imperfections in vision, which will help them create lenses that fit better and improve eyesight and comfort for patients. The study is observational, meaning participants will not receive any experimental treatments; instead, they will provide important data for future lens development.

To be eligible for this study, participants must be at least 18 years old and have a diagnosis of keratoconus or another corneal ectatic disorder. They should also have a stable cornea, which means no recent surgeries or complications. Participants will undergo scans of their eyes to gather the necessary information, and even if only one eye has keratoconus, both eyes will be included in the scans. It’s important for potential participants to be aware that certain eye conditions and recent contact lens changes may prevent them from joining the study. Overall, this research aims to help improve vision solutions for those dealing with these eye conditions.

Gender

ALL

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.