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Completed

NCT Number: NCT03187912

Accelerated Corneal Cross-linking With Different Riboflavin Solutions

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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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna, Department of Ophthalmology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riboflavin

Drug

Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively

Primary outcomes

  1. Kmax

    Time frame: 12 months

    Steepest Keratometry

Secondary outcomes

  1. Postoperative central stromal depth of the Demarcation Line

    Time frame: 1 month

    The depth of the Demarcation Line after CXL will be measured one month postoperatively with an AS-OCT

  2. LogMAR

    Time frame: 12 months

    Visual Acuity

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 15, 2017
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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