KeratoconusPhase 3NCT01190306
Safety Study of the VEGA UV-A System to Treat Keratoconus
A Phase 3 study testing The VEGA UV-A Illumination System and Riboflavin in people with Keratoconus, run by Topcon Medical Systems, Inc. at 9 sites in United States.
Trial summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- The VEGA UV-A Illumination System and Riboflavin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2010to Dec 2011
- 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
- Having a diagnosis of keratoconus
- Presence of central or inferior steepening
- Topography consistent with keratoconus
- Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
- Contact lens wearers only:Removal of contact lenses for the 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 or the insertion of Intacs in the eye to be treated
- Corneal pachymetry ≤ 400 microns
- Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
Show all 9Show fewer
- Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
- A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Woolfson Eye Institute
Atlanta, Georgia, 30328
Dell Laser Consultants
Austin, Texas, 78746
Minnesota Eye Consultants
Bloomington, Minnesota, 55431
OSU Department of Ophthalmoloty
Columbus, Ohio, 43212
Revision Advanced Laser Eye Center
Columbus, Ohio, 43240
Slade & Baker Vision Center
Houston, Texas, 77027
Pamel Vision & Laser Group
New York, New York, 10021
Mt. Sinai Hospital
New York, New York, 10029
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016
About this study
Official title: Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.
- Conditions
- Keratoconus
- Being tested
- The VEGA UV-A Illumination System, Riboflavin
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The VEGA UV-A Illumination SystemDevice
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
RiboflavinDrug
Riboflavin is a solution that will be delivered to the treatment area
| Study group | Role | What they receive |
|---|---|---|
| CXL Treatment | Experimental | Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light. Receives: Device: The VEGA UV-A Illumination System; Drug: Riboflavin |
| Sham Control | Active comparator | Eyes in the control group will be treated with riboflavin only. Receives: Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corneal Curvature.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: The sponsor terminated the study prior to data analysis for financial reasons.
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 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 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
- NCT01190306
- Sponsor's protocol ID
- CXL-001
- Status last verified
- Jul 2022
- First submitted
- 25 Aug 2010
- Last updated
- 12 Jul 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus
- ClinicalTrials.gov ID
- NCT01190306
- Acronym / sponsor ID
- CXL-001
- Conditions
- Keratoconus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor terminated the study prior to data analysis for financial reasons.
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Aug 2010 (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 test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CXL Treatment | Experimental | Device: The VEGA UV-A Illumination System, Drug: RiboflavinEyes randomized to the CXL treatment group with be treated with riboflavin and UV light. |
| Sham Control | Active comparator | Drug: RiboflavinEyes in the control group will be treated with riboflavin only. |
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
- Having a diagnosis of keratoconus
- Presence of central or inferior steepening
- Topography consistent with keratoconus
- Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
Key exclusion criteria (9 listed)
- For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
- Corneal pachymetry ≤ 400 microns
- Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
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 |
|---|---|---|
| The 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 |
| RiboflavinRiboflavin is a solution that will be delivered to the treatment area | Drug | CXL Treatment, Sham Control |
Primary outcome
Change in Corneal Curvature.
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
9 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 The VEGA UV-A Illumination System and Riboflavin in people with Keratoconus, run by Topcon Medical Systems, Inc. at 9 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 9 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Change in Corneal Curvature. (time frame: 6 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 12 Jul 2022.