Keratoconus
Conditions
Brief summary
Following the Bunsen-Roscoe law, accelerated cross-linking protocols with higher irradiation intensities and shorter irradiation times have been introduced. In addition, new riboflavin solutions with HPMC (hydroxylpropyl methylcellulose) instead of dextran found its way into CXL-treatment. The aim of this trial is to evaluate clinical outcomes in an accelerated corneal collagen cross-linking protocol with different riboflavin solutions.
Interventions
DRUGRiboflavin
Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Progressive Keratoconus * Indication for treatment * Preoperative Pachymetry \> 400
Exclusion criteria
* Pregnancy * Re-CXL * Keratitis * Other visual acuity limiting eye diseases than corneal ectatic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kmax | 12 months | Steepest Keratometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative central stromal depth of the Demarcation Line | 1 month | The depth of the Demarcation Line after CXL will be measured one month postoperatively with an AS-OCT |
| LogMAR | 12 months | Visual Acuity |
Countries
Austria
Outcome results
None listed