Keratoconus and EctasiaPhase 3NCT01398852
Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia
A Phase 3 study testing Riboflavin and VEGA UV-A Illumination System in people with Keratoconus and Ectasia, run by Topcon Medical Systems, Inc. at 13 sites in United States.
Trial summary
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keratoconus and Ectasia
- What is being tested?
- Riboflavin and VEGA UV-A Illumination System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2010to Jul 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older
- Diagnosis of Keratoconus or Ectasia
- Central or Inferior steepening on the Pentacam map
- Topography consistent with Keratoconus or Ectasia
- BSCVA 20/20 or worse
- Removal of contact lenses for required period of time
- Signed written informed consent
- Willingness and ability to comply with schedule for follow up visits
Who cannot join
- For Keratoconus, a history of previous corneal surgery
- Corneal pachymentry equal to or greater and 400
- Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
- A history of chemical injury or delayed healing
- Pregnancy
- A known sensitivity to the study medications
- Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
- Presence or history of any other condition or finding that makes the patient unsuitable as a candidate
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Woolfson Eye Institute
Atlanta, Georgia
Dell Laser Consultants
Austin, Texas
Minnesota Eye Consultants
Bloomington, Minnesota
Massachusetts Eye And Ear Infirmary
Boston, Massachusetts
Cleveland Clinic-Cole Eye Institute
Cleveland, Ohio, 44195
ReVision Advanced Laser Eye Center
Columbus, Ohio, 43240
OSU Department of Ophthalomogy
Columbus, Ohio
Slade and Baker Vision Center
Houston, Texas
Laser and Corneal Surgery Assoc. PC
New York, New York, 10022
Mt Sinai Hospital
New York, New York
Pamel Vision & Laser Group
New York, New York
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona
The Eye Institute of Utah
Salt Lake City, Utah, 84107
About this study
Official title: Long Term Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Post-Refractive Corneal Ectasia
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.
- Conditions
- Keratoconus and Ectasia
- Being tested
- Riboflavin, VEGA UV-A Illumination System
- 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.
RiboflavinDrug
Riboflavin is a solution that will be delivered to the treatment area
VEGA UV-A Illumination SystemDevice
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
| Study group | Role | What they receive |
|---|---|---|
| CXL Treatment | Experimental | All eyes to be treated with riboflavin and UV light Receives: Drug: Riboflavin; Device: VEGA UV-A Illumination System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Corneal Curvature
Measured: 24 MO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Keratoconus and EctasiaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398852
- Sponsor's protocol ID
- CXL-003
- Status last verified
- Jun 2022
- First submitted
- 11 Jul 2011
- Last updated
- 29 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Post-Refractive Corneal Ectasia
- ClinicalTrials.gov ID
- NCT01398852
- Acronym / sponsor ID
- CXL-003
- Conditions
- Keratoconus and Ectasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Posted 4 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CXL Treatment | Experimental | Drug: Riboflavin, Device: VEGA UV-A Illumination SystemAll eyes to be treated with riboflavin and UV light |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 12 years of age or older
- Diagnosis of Keratoconus or Ectasia
- Central or Inferior steepening on the Pentacam map
- Topography consistent with Keratoconus or Ectasia
- BSCVA 20/20 or worse
Key exclusion criteria (8 listed)
- For Keratoconus, a history of previous corneal surgery
- Corneal pachymentry equal to or greater and 400
- Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
- A history of chemical injury or delayed healing
- Pregnancy
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 is a solution that will be delivered to the treatment area | Drug | CXL Treatment |
| VEGA UV-A Illumination SystemThis is a portable electronic device designed to deliver a dose of UV-A light to the treatment area | Device | CXL Treatment |
Primary outcome
Changes in Corneal Curvature
Time frame: 24 MO
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Keratoconus and Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Recruiting
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
Keratoconus, Post-Laser Retinal Condition
RecruitingPhase 2
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
Keratoconus, Pellucid Marginal Corneal Degeneration
RecruitingPhase 1
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
Keratoconus, Unstable, Bacterial Keratitis
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.
13 sites 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 and VEGA UV-A Illumination System in people with Keratoconus and Ectasia, run by Topcon Medical Systems, Inc. at 13 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 8 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 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
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?
Yes. Results are posted in the registry (first posted 4 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Corneal Curvature (time frame: 24 MO). 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 29 Jun 2022.