Corneal EctasiaKC-DATANCT06859398
KeratoConus Data Acquisition With Topography and Aberrometry
A study testing Ocular Topography and Wavefront Aberrometry in people with Corneal Ectasia and Keratoconus, run by Azalea Vision at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Ectasia, Keratoconus
- What is being tested?
- Ocular Topography and Wavefront Aberrometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jun 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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
- Being tested
- Ocular Topography and Wavefront Aberrometry
- Keywords
- Keratoconus, Corneal ectasia, Wavefront aberrometry, Corneal topography, Scleral topography, Ocular topography, Irregular corneal condition
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular Topography and Wavefront AberrometryOther
Eyescan with Pentacam AXL Wave
| Study group | Role | What they receive |
|---|---|---|
| Keratoconus and corneal ectasia | Other | wavefront aberrometry and topography measurement through Pentacam AXL Wave device Receives: Other: Ocular Topography and Wavefront Aberrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Topography
Mapping of the ocular surface
Measured: during the Eyescan procedure
Wavefront aberrometry
Quantification of the wavefront aberrations
Measured: during the Eyescan procedure
Secondary outcomes (8)
Ocular Topography
Description of the percentage of ocular surface mapped during topography measurement
Measured: during the Eyescan procedure
Ocular Topography
Repeatability of topography measurements between different scans will be assessed
Measured: 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
Measured: during the Eyescan procedure
Wavefront aberrometry
Quality of aberrometric measurements based on full sequence quality specification embedded in the Oculus Pentacam AXL Wave
Measured: during the Eyescan procedure
Anterior chamber depth
as measured by the Pentacam AXL Wave.
Measured: during the Eyescan procedure
Axial length
as measured by the Pentacam AXL Wave
Measured: during the Eyescan procedure
Pupillometry
measurement of pupil size during aberrometry measurement
Measured: during the Eyescan procedure
Distribution level of keratoconus severity
using the parameters embedded in the Oculus Pentacam AXL Wave
Measured: during the Eyescan procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start16 Jun 2025
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EctasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azalea Vision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koppen, Prof. Dr., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859398
- Sponsor's protocol ID
- Az01
- Acronym
- KC-DATA
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection Study in Keratoconus, Utilizing Topography and Wavefront Aberrometry
- ClinicalTrials.gov ID
- NCT06859398
- Acronym / sponsor ID
- KC-DATA / Az01
- Conditions
- Corneal Ectasia, Keratoconus
- Keywords
- Keratoconus, Corneal ectasia, Wavefront aberrometry, Corneal topography, Scleral topography, Ocular topography, Irregular corneal condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Azalea VisionIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Keratoconus and corneal ectasia | Other | Other: Ocular Topography and Wavefront Aberrometrywavefront aberrometry and topography measurement through Pentacam AXL Wave device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular Topography and Wavefront AberrometryEyescan with Pentacam AXL Wave | Other | Keratoconus and corneal ectasia |
Primary outcome
Ocular Topography
Time frame: during the Eyescan procedure
Mapping of the ocular surface
Wavefront aberrometry
Time frame: during the Eyescan procedure
Quantification of the wavefront aberrations
8 secondary outcomes
Ocular Topography
Time frame: during the Eyescan procedure
Ocular Topography
Time frame: during the Eyescan procedure
Ocular Topography
Time frame: during the Eyescan procedure
Wavefront aberrometry
Time frame: during the Eyescan procedure
Anterior chamber depth
Time frame: during the Eyescan procedure
Axial length
Time frame: during the Eyescan procedure
Pupillometry
Time frame: during the Eyescan procedure
Distribution level of keratoconus severity
Time frame: during the Eyescan procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Corneal Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
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RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Not yet recruitingPhase 4
Outcomes of CTAK Surgery
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RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koppen, Prof. Dr. principal investigator
University Hospital, Antwerp
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular Topography and Wavefront Aberrometry in people with Corneal Ectasia and Keratoconus, run by Azalea Vision at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Topography (time frame: during the Eyescan procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.