Efficacy of Customized Corneal Cross-linking vs. Standard Corneal Cross-linking (C-CROSS)
Keratoconus
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Crosslinking, Customized
Eligibility Criteria
Inclusion Criteria:
- Progressive keratoconus based on an increase of maximum keratometry (Kmax) of 1 diopter (D) over a time period of 12 months
Exclusion Criteria:
- Corneal scarring
- Corneal disease other than keratoconus
- History of corneal surgery (e.g. refractive surgery, corneal transplantation, intracorneal ring segments)
- Patient unwilling or unable to give informed consent, unwilling to accept randomization or inability to complete follow-up (e.g. hospital visits) or comply with study procedures
- Insufficient corneal thickness including epithelium < 375 µm
- Pregnancy
- Among patients in whom both eyes are eligible only the first eye which is undergoing corneal cross-linking is enrolled in the study
- Participation in another clinical study
Sites / Locations
- Maastricht University Medical Center (MUMC+)Recruiting
- University Medical Center GroningenRecruiting
- University Medical Center Utrecht
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Customized crosslinking
Standard crosslinking
In the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size. The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States).
In the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2. The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States).