Data Collection Study in Keratoconus, Utilizing Topography and Wavefront Aberrometry

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
University Hospital Antwerp (UZA)
RECRUITING
Edegem
Netherlands
Visser Contactlenzen Brunssum
RECRUITING
Brunssum
Contact Information
Primary
Lieselot Burggraeve
lieselot@azaleavision.com
+3292928071
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 55
Treatments
Other: Keratoconus and corneal ectasia
wavefront aberrometry and topography measurement through Pentacam AXL Wave device
Related Therapeutic Areas
Sponsors
Leads: Azalea Vision

This content was sourced from clinicaltrials.gov