KeratoConus Data Acquisition With Topography and Aberrometry

NCT06859398 | Completed

• 1 other identifier: Az01
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 2

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.

Conditions

Corneal Ectasia; Keratoconus

Keywords

Keratoconus; Corneal ectasia; Wavefront aberrometry; Corneal topography; Scleral topography; Ocular topography; Irregular corneal condition

Outcome Measures

Primary Outcomes (2)

• Ocular Topography

  Mapping of the ocular surface

  during the Eyescan procedure

• Wavefront aberrometry

  Quantification of the wavefront aberrations

  during the Eyescan procedure

Secondary Outcomes (8)

• Ocular Topography

  during the Eyescan procedure

• Ocular Topography

  during the Eyescan procedure

• Ocular Topography

  during the Eyescan procedure

• Wavefront aberrometry

  during the Eyescan procedure

• Anterior chamber depth

  during the Eyescan procedure

Study Arms (1)

Keratoconus and corneal ectasia

OTHER

wavefront aberrometry and topography measurement through Pentacam AXL Wave device

Other: Ocular Topography and Wavefront Aberrometry

Interventions

Ocular Topography and Wavefront Aberrometry OTHER

Eyescan with Pentacam AXL Wave

Keratoconus and corneal ectasia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azalea Vision: lead

Study Sites (2)

University Hospital Antwerp (UZA)

Edegem, 2650, Belgium

Location

Visser Contactlenzen Brunssum

Brunssum, 6443, Netherlands

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Koppen, Prof. Dr.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is considered as a data collection study. The data which will be collected within this study, is not collected per standard of care. Depending on the participating country, the study is considered interventional

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 5, 2025
• Study Start: June 16, 2025
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); BE (1)