KeratoconusNCT01097447
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)
An observational study of Keratoconus and Ectasia, run by Cxlusa at 5 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
- How many people
- 2,619 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Dec 2009to 30 Apr 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.
- Ability to provide written informed consent
- Likely to complete all study visits
- Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam
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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, 55431
Cornea Associates of Texas
Dallas, Texas, 75231
Chicago Cornea Consultants, LTD
Hoffman Estates, Illinois
Corneal Consultants of Colorado, P.C
Littleton, Colorado
Clear View Eye & Laser Medical Center
San Diego, California, 92121
About this study
Official title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
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
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxicine or Vigamox or other | up to qid till epithelialized. | |
| Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom | up to qid for up to 5-10 days postop | |
| Topical steroid (FML, Pred Forte, Flarex | qid for up to 8 weeks |
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 posted1 Apr 2010 (estimated)
- Study start1 Dec 2009
- Primary completion30 Apr 2017
- Study completion30 Apr 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
- 2,619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cxlusa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Parag Majmudar, MD, Principal investigator, Chicago Cornea Consultants, LTDLance Forstot, MD, Principal investigator, Corneal Consultants of Colorado, P.CBradley Bowman, M.D, Principal investigator, Cornea Associates of TexasSandy Feldman, M.D, Principal investigator, Clear View Eye & Laser Medical CenterSherman Reeves, MD, Principal investigator, Minnesota Eye Consultants, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097447
- Sponsor's protocol ID
- CXL (2)
- Status last verified
- Oct 2018
- First submitted
- 25 Mar 2010
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- NCT01097447
- Acronym / sponsor ID
- CXL (2)
- 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
- 2,619 participants (actual)
- Lead sponsor
- CxlusaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2009 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 1 Apr 2010 (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 | – | –up to qid till epithelialized. |
| Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom | – | –up to qid for up to 5-10 days postop |
| Topical steroid (FML, Pred Forte, Flarex | – | –qid for up to 8 weeks |
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 (7 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.
- Ability to provide written informed consent
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.
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.
- Individual participant dataSharing planned: No
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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.
Parag Majmudar, MD principal investigator
Chicago Cornea Consultants, LTD
Lance Forstot, MD principal investigator
Corneal Consultants of Colorado, P.C
Bradley Bowman, M.D principal investigator
Cornea Associates of Texas
5 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 5 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 7 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 5 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.