KeratoconusPhase 3NCT01682993
Corneal Cross Linking and Topography Guided Excimer Laser Treatment
A Phase 3 study testing Topography guided Excimer Laser treatment and Corneal Cross Linking and Corneal Cross Linking in people with Keratoconus and Pellucid Marginal Degeneration, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. Several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (CCL) in patients with ectatic corneal diseases. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Keratoconus, Pellucid Marginal Degeneration
- What is being tested?
- Topography guided Excimer Laser treatment and Corneal Cross Linking and Corneal Cross Linking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2010to Dec 2015
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Patient age 18 - 40 years
- Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia
Who cannot join
- Allergy to one of the used substances
- Tendency towards excessive scar formation
- Pregnancy
- Rheumatic diseases
- Central corneal thickness below 450 µm
- Active infection of the study eye
- Previous corneal surgery of the study eye
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: Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.
Topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. Several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (CCL) in patients with ectatic corneal diseases.
This randomized study will evaluate the safety and efficacy of a combined treatment of corneal cross linking with a partial topography guided excimer laser treatment in eyes with progressive ectatic corneal diseases.
- Conditions
- Keratoconus, Pellucid Marginal Degeneration
- Being tested
- Topography guided Excimer Laser treatment and Corneal Cross Linking, Corneal Cross Linking
- Keywords
- corneal cross linking, topography guided excimer laser, Keratoconus, Pellucid marginal degeneration, Post Excimer ectasia
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topography guided Excimer Laser treatment and Corneal Cross LinkingOther
A topography guided excimer laser treatment will be performed prior to CCL in one session.
Corneal Cross LinkingOther
A standard corneal cross linking procedure will be performed in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Corneal Cross Linking | Active comparator | Patients will receive a standard corneal cross linking treatment Receives: Other: Corneal Cross Linking |
| Corneal Cross Linking and Topo Laser | Experimental | Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session. Receives: Other: Topography guided Excimer Laser treatment and Corneal Cross Linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Pachymetry, K-readings)
Measured: 1 year
uncorrected visual acuity (UVCA)
Measured: 1 year
best corrected visual acuity (BCVA)
Measured: 1 year
Secondary outcomes (1)
Progression of ectatic disease (by use of maximum keratometry readings = Kmax)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2015
- Study completionDec 2015
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
- None (open label)
- Enrolment
- 30 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
- NCT01682993
- Sponsor's protocol ID
- 367/2009
- Status last verified
- Apr 2017
- First submitted
- 5 Nov 2011
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.
- ClinicalTrials.gov ID
- NCT01682993
- Acronym / sponsor ID
- 367/2009
- Conditions
- Keratoconus, Pellucid Marginal Degeneration
- Keywords
- corneal cross linking, topography guided excimer laser, Keratoconus, Pellucid marginal degeneration, Post Excimer ectasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Sep 2012 (estimated)
- 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.
Topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. Several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (CCL) in patients with ectatic corneal diseases.
This randomized study will evaluate the safety and efficacy of a combined treatment of corneal cross linking with a partial topography guided excimer laser treatment in eyes with progressive ectatic corneal diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal Cross Linking | Active comparator | Other: Corneal Cross LinkingPatients will receive a standard corneal cross linking treatment |
| Corneal Cross Linking and Topo Laser | Experimental | Other: Topography guided Excimer Laser treatment and Corneal Cross LinkingPatients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Patient age 18 - 40 years
- Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia
Key exclusion criteria (7 listed)
- Allergy to one of the used substances
- Tendency towards excessive scar formation
- Pregnancy
- Rheumatic diseases
- Central corneal thickness below 450 µm
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 |
|---|---|---|
| Topography guided Excimer Laser treatment and Corneal Cross LinkingA topography guided excimer laser treatment will be performed prior to CCL in one session. | Other | Corneal Cross Linking and Topo Laser |
| Corneal Cross LinkingA standard corneal cross linking procedure will be performed in this arm. | Other | Corneal Cross Linking |
Primary outcome
Safety (Pachymetry, K-readings)
Time frame: 1 year
uncorrected visual acuity (UVCA)
Time frame: 1 year
best corrected visual acuity (BCVA)
Time frame: 1 year
1 secondary outcome
Progression of ectatic disease (by use of maximum keratometry readings = Kmax)
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
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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 Topography guided Excimer Laser treatment and Corneal Cross Linking and Corneal Cross Linking in people with Keratoconus and Pellucid Marginal Degeneration, 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 7 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: stopped early, as of the sponsor's last update on 26 Apr 2017. 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 was stopped early. Results are not available in the source record.
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?
Safety (Pachymetry, K-readings) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 26 Apr 2017.