NCT03187912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

3.5 years

First QC Date

June 12, 2017

Last Update Submit

March 2, 2021

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Kmax

    Steepest Keratometry

    12 months

Secondary Outcomes (2)

  • Postoperative central stromal depth of the Demarcation Line

    1 month

  • LogMAR

    12 months

Study Arms (2)

Riboflavin with 20% Dextran

ACTIVE COMPARATOR

Riboflavin drops with Dextran

Drug: Riboflavin

Riboflavin with HPMC

ACTIVE COMPARATOR

Riboflavin drops with HPMC

Drug: Riboflavin

Interventions

RiboflavinDRUG

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

Riboflavin with 20% DextranRiboflavin with HPMC

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Progressive Keratoconus
  • Indication for treatment
  • Preoperative Pachymetry \> 400

You may not qualify if:

  • Pregnancy
  • Re-CXL
  • Keratitis
  • Other visual acuity limiting eye diseases than corneal ectatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Ophthalmology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. PDDr.

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 15, 2017

Study Start

September 19, 2016

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

AU(1)