Accelerated Corneal Cross-linking With Different Riboflavin Solutions

NCT ID: NCT03187912

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2020-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Riboflavin with 20% Dextran

Riboflavin drops with Dextran

Group Type ACTIVE_COMPARATOR

Riboflavin

Intervention Type DRUG

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

Riboflavin with HPMC

Riboflavin drops with HPMC

Group Type ACTIVE_COMPARATOR

Riboflavin

Intervention Type DRUG

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

Interventions

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Riboflavin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerald Schmidinger

Ass. Prof. PDDr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna, Department of Ophthalmology

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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1390/2016

Identifier Type: -

Identifier Source: org_study_id

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