Accelerated Corneal Cross-linking With Different Riboflavin Solutions

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Keratoconus

Treatments: Drug: Riboflavin

Study type: Interventional

Funder types: Other

Identifiers

NCT03187912

1390/2016

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

Riboflavin with 20% Dextran

Active Comparator group

Description:

Riboflavin drops with Dextran

Treatment:

Drug: Riboflavin

Riboflavin with HPMC

Active Comparator group

Description:

Riboflavin drops with HPMC

Treatment:

Drug: Riboflavin