EctasiaPhase 3NCT01398839
Safety Study of the VEGA UV-A System to Treat Ectasia
A Phase 3 study testing VEGA UV-A Illumination System and Riboflavin in people with Ectasia, run by Topcon Medical Systems, Inc. at 12 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 ectasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ectasia
- What is being tested?
- VEGA UV-A Illumination System and Riboflavin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 12 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years of age or older
- Diagnosis of Ectasia
- Presence of central or inferior steepening
- Topography consistent with ectasia
- BSCVA 20/20 or worse
- If contact lens wearer; removal of contact lenses for required period of time
- Signed informed consent
- Willingness and ability to comply with schedule for follow-up visits
Who cannot join
- Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
- History of chemical injury or delayed epithelial healing
- A known sensitivity to study medications
- Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
- A condition that would interfere with or prolong epithelial healing
- Presence or history of any other condition or finding that makes the patient unsuitable for treatment
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Woolfson Eye Institute
Atlanta, Georgia
Dell Laser Consultants
Austin, Texas
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, 55431
Cleveland Clinic-Cole Eye Institute
Cleveland, Ohio, 44195
The Ohio State University College of Medicine
Columbus, Ohio, 43212
ReVision Advanced Laser Eye Center
Columbus, Ohio, 43240
Slade & Baker Vision
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
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.
- Conditions
- Ectasia
- Being tested
- VEGA UV-A Illumination System, Riboflavin
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGA UV-A Illumination SystemDevice
Only subjects assigned to the treatment group will receive treatment with the UV Light
RiboflavinDrug
Both treatment and sham groups will receive riboflavin
| Study group | Role | What they receive |
|---|---|---|
| Sham Control | Sham comparator | Not described Receives: Drug: Riboflavin |
| CXL Treatment | Experimental | Not described Receives: Device: VEGA UV-A Illumination System; Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes 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 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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 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
- NCT01398839
- Sponsor's protocol ID
- CXL-002
- Status last verified
- Jun 2022
- First submitted
- 10 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
- Safety Study of the VEGA UV-A System to Treat Ectasia
- ClinicalTrials.gov ID
- NCT01398839
- Acronym / sponsor ID
- CXL-002
- Conditions
- Ectasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 103 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 test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Control | Sham comparator | Drug: Riboflavin |
| CXL Treatment | Experimental | Device: VEGA UV-A Illumination System, Drug: Riboflavin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 Years of age or older
- Diagnosis of Ectasia
- Presence of central or inferior steepening
- Topography consistent with ectasia
- BSCVA 20/20 or worse
Key exclusion criteria (6 listed)
- Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
- History of chemical injury or delayed epithelial healing
- A known sensitivity to study medications
- Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
- A condition that would interfere with or prolong epithelial healing
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 |
|---|---|---|
| VEGA UV-A Illumination SystemOnly subjects assigned to the treatment group will receive treatment with the UV Light | Device | CXL Treatment |
| RiboflavinBoth treatment and sham groups will receive riboflavin | Drug | CXL Treatment, Sham Control |
Primary outcome
Changes 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 29 Jun 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.
12 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 VEGA UV-A Illumination System and Riboflavin in people with Ectasia, run by Topcon Medical Systems, Inc. at 12 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 6 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 12 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. Some participants in this study may receive a placebo. 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: 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 29 Jun 2022.