Accelerated Corneal Cross-linking With Different Riboflavin Solutions

NCT03187912 — Phase 3, Completed, 60 participants, Medical University of Vienna

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Effect-evaluation of an Accelerated Corneal Cross-linking Protocol With Different Riboflavin Solutions

Registry	NCT03187912
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	60 (Actual)
Sponsor	Medical University of Vienna (Other)
Conditions	Keratoconus
Interventions	Riboflavin (Drug)
Dates	start 2016-09-19, primary completion 2020-03-30, completion 2020-03-30, first posted 2017-06-15, last updated 2021-03-03
Locations	1 site in Austria

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Riboflavin with 20% Dextran	Active comparator	Drug: Riboflavin	Riboflavin drops with Dextran
Riboflavin with HPMC	Active comparator	Drug: Riboflavin	Riboflavin drops with HPMC

Riboflavin (Drug): 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 outcomes

Kmax [12 months]: Steepest Keratometry

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 99 Years

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

+Locations (1)

Facility	City	Country	Status
Medical University of Vienna, Department of Ophthalmology	Vienna	Austria

My Notes

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