KeratoConus Data Acquisition With Topography and Aberrometry (KC-DATA)

Data Collection Study in Keratoconus, Utilizing Topography and Wavefront Aberrometry

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.

Study Overview

• Status: Completed
• Conditions: Keratoconus; Corneal Ectasia
• Intervention / Treatment: Other: Ocular Topography and Wavefront Aberrometry

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • University Hospital Antwerp (UZA)
• Netherlands
  • Brunssum, Netherlands, 6443
    • Visser Contactlenzen Brunssum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Keratoconus and corneal ectasia; wavefront aberrometry and topography measurement through Pentacam AXL Wave device	Other: Ocular Topography and Wavefront Aberrometry; Eyescan with Pentacam AXL Wave

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Azalea Vision
• Investigators: Principal Investigator: Koppen, Prof. Dr., University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Actual): November 20, 2025
• Study Completion (Actual): November 20, 2025

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Keratoconus; Corneal topography; Corneal ectasia; Wavefront aberrometry; Scleral topography; Ocular topography; Irregular corneal condition
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: Az01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No