KeratoConus Data Acquisition With Topography and Aberrometry

NCT ID: NCT06859398

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2025-11-20

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.

Conditions

Corneal Ectasia; Keratoconus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Keratoconus and corneal ectasia

wavefront aberrometry and topography measurement through Pentacam AXL Wave device

Group Type: OTHER

Ocular Topography and Wavefront Aberrometry

Intervention Type: OTHER

Eyescan with Pentacam AXL Wave

Interventions

Ocular Topography and Wavefront Aberrometry

Eyescan with Pentacam AXL Wave

Intervention Type: OTHER

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azalea Vision

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koppen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital Antwerp (UZA)

Edegem, , Belgium

Visser Contactlenzen Brunssum

Brunssum, , Netherlands

Countries

Belgium; Netherlands

Other Identifiers

Az01

Identifier Type: -

Identifier Source: org_study_id