KeratoconusNCT01024322
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
An observational study of Keratoconus and Ectasia, run by Cxlusa at 3 sites in United States.
Trial summary
To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Keratoconus, Ectasia, Degeneration
- What is being tested?
- Ciprofloxicine or Vigamox or other., Nonsteroidal (Acular, Voltaren Xibrom, etc) and Steroid (FML, Pred Forte, Flarex, etc.)
- How many people
- 1,189 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2009to 3 Feb 2017
- Phase
- Observational
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic.
Who may be able to join
- 8 years of age or older
- Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
- Diagnosis of FFKC
- History of Radial Keratotomy with fluctuating vision.
- Terrien's Marginal Degeneration
- Ability to provide written informed consent
- Likely to complete all study visits
- Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.
Who cannot join
- Severe corneal scarring that markedly affects vision
- Contraindications to any study medications or their components
- Pregnancy or breast feeding
- Active Herpes Corneal Disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
TLC Laser Eye Center
Fairfax, Virginia, 22031
The Center for Excellence in Eye Care
Miami, Florida, 33176
TLC Laser Eye Center
Rockville, Maryland, 20852
About this study
To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication
- Conditions
- Keratoconus, Ectasia, Degeneration
- Being tested
- Ciprofloxicine or Vigamox or other., Nonsteroidal (Acular, Voltaren Xibrom, etc), Steroid (FML, Pred Forte, Flarex, etc.)
- Keywords
- Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration
- Medical subject headings
- Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxicine or Vigamox or other.Drug
Ciprofloxicine or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Voltaren Xibrom, etc)Drug
Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.)Drug
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxicine or Vigamox or other. | Not described Receives: Drug: Ciprofloxicine or Vigamox or other. | |
| Nonsteroidal (Acular, Voltaren Xibrom, etc) | Not described Receives: Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc) | |
| Steroid (FML, Pred Forte, Flarex, etc.) | Not described Receives: Drug: Steroid (FML, Pred Forte, Flarex, etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
Measured: 1 year
Secondary outcomes (1)
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
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 posted2 Dec 2009 (estimated)
- Study start1 Oct 2009
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
Why it stopped: Terminated to initiate FDA IND-cleared study protocol
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cxlusa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Trattler, MD, Principal investigator, The Center for Excellence in Eye CareRoy Rubinfeld, MD, Principal investigator, Re: Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024322
- Sponsor's protocol ID
- CXL
- Status last verified
- Sep 2018
- First submitted
- 28 Oct 2009
- Last updated
- 11 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
- ClinicalTrials.gov ID
- NCT01024322
- Acronym / sponsor ID
- CXL
- Conditions
- Keratoconus, Ectasia, Degeneration
- Keywords
- Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated to initiate FDA IND-cleared study protocol
- Enrolment
- 1,189 participants (actual)
- Lead sponsor
- CxlusaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 2 Dec 2009 (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.
To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxicine or Vigamox or other. | – | Drug: Ciprofloxicine or Vigamox or other. |
| Nonsteroidal (Acular, Voltaren Xibrom, etc) | – | Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc) |
| Steroid (FML, Pred Forte, Flarex, etc.) | – | Drug: Steroid (FML, Pred Forte, Flarex, etc.) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic.
Key inclusion criteria (8 listed)
- 8 years of age or older
- Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
- Diagnosis of FFKC
- History of Radial Keratotomy with fluctuating vision.
- Terrien's Marginal Degeneration
Key exclusion criteria (4 listed)
- Severe corneal scarring that markedly affects vision
- Contraindications to any study medications or their components
- Pregnancy or breast feeding
- Active Herpes Corneal Disease
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 |
|---|---|---|
| Ciprofloxicine or Vigamox or other.Ciprofloxicine or Vigamox or other to be used qid till epithelialized. | Drug | Ciprofloxicine or Vigamox or other. |
| Nonsteroidal (Acular, Voltaren Xibrom, etc)Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op | Drug | Nonsteroidal (Acular, Voltaren Xibrom, etc) |
| Steroid (FML, Pred Forte, Flarex, etc.)Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks. | Drug | Steroid (FML, Pred Forte, Flarex, etc.) |
Primary outcome
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
Time frame: 1 year
1 secondary outcome
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Terminated to initiate FDA IND-cleared study protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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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.
William Trattler, MD principal investigator
The Center for Excellence in Eye Care
Roy Rubinfeld, MD principal investigator
Re: Vision
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus and Ectasia, run by Cxlusa at 3 sites in United States.
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 8 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: stopped early, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
The study was stopped early (reason given: Terminated to initiate FDA IND-cleared study protocol). 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?
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within (time frame: 1 year). 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 11 Oct 2018.