KeratoconusPhase 3NCT03187912
Accelerated Corneal Cross-linking With Different Riboflavin Solutions
A Phase 3 study testing Riboflavin in people with Keratoconus, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 19 Sep 2016to 30 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Progressive Keratoconus
- Indication for treatment
- Preoperative Pachymetry > 400
Who cannot join
- Pregnancy
- Re-CXL
- Keratitis
- Other visual acuity limiting eye diseases than corneal ectatic diseases
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Ophthalmology
Vienna, 1090
About this study
Official title: Effect-evaluation of an Accelerated Corneal Cross-linking Protocol 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.
- Conditions
- Keratoconus
- Being tested
- Riboflavin
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinDrug
Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively
| Study group | Role | What they receive |
|---|---|---|
| Riboflavin with 20% Dextran | Active comparator | Riboflavin drops with Dextran Receives: Drug: Riboflavin |
| Riboflavin with HPMC | Active comparator | Riboflavin drops with HPMC Receives: Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kmax
Steepest Keratometry
Measured: 12 months
Secondary outcomes (2)
Postoperative central stromal depth of the Demarcation Line
The depth of the Demarcation Line after CXL will be measured one month postoperatively with an AS-OCT
Measured: 1 month
LogMAR
Visual Acuity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start19 Sep 2016
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald Schmidinger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187912
- Sponsor's protocol ID
- 1390/2016
- Status last verified
- Mar 2021
- First submitted
- 12 Jun 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect-evaluation of an Accelerated Corneal Cross-linking Protocol With Different Riboflavin Solutions
- ClinicalTrials.gov ID
- NCT03187912
- Acronym / sponsor ID
- 1390/2016
- Conditions
- Keratoconus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riboflavin with 20% Dextran | Active comparator | Drug: RiboflavinRiboflavin drops with Dextran |
| Riboflavin with HPMC | Active comparator | Drug: RiboflavinRiboflavin drops with HPMC |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Progressive Keratoconus
- Indication for treatment
- Preoperative Pachymetry > 400
Key exclusion criteria (4 listed)
- Pregnancy
- Re-CXL
- Keratitis
- Other visual acuity limiting eye diseases than corneal ectatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiboflavinRiboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively | Drug | Riboflavin with 20% Dextran, Riboflavin with HPMC |
Primary outcome
Kmax
Time frame: 12 months
Steepest Keratometry
2 secondary outcomes
Postoperative central stromal depth of the Demarcation Line
Time frame: 1 month
LogMAR
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Riboflavin in people with Keratoconus, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kmax (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.