Accelerated Corneal Cross-linking With Different Riboflavin Solutions

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT03187912
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 42.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Drug: Riboflavin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect-evaluation of an Accelerated Corneal Cross-linking Protocol With Different Riboflavin Solutions
• Actual Study Start Date: Sep 19, 2016
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Riboflavin with 20% Dextran Riboflavin drops with Dextran	Drug: Riboflavin; Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively
Active Comparator: Riboflavin with HPMC Riboflavin drops with HPMC	Drug: Riboflavin; Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively

Outcome Measures

Primary Outcome Measures

1. Kmax [12 months]

   Steepest Keratometry

Secondary Outcome Measures

1. 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

2. LogMAR [12 months]

   Visual Acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, Department of Ophthalmology	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerald Schmidinger, Ass. Prof. PDDr., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT03187912
• Other Study ID Numbers: 1390/2016
• First Posted: Jun 15, 2017
• Last Update Posted: Mar 3, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Keratoconus; Riboflavin

Study Results

No Results Posted as of Mar 3, 2021