A Phase 3 interventional study of Riboflavin and VEGA UV-A Illumination System in Keratoconus and Ectasia, sponsored by Topcon Medical Systems, Inc.. Terminated at 13 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-06-29.
Sponsored by Topcon Medical Systems, Inc. · Phase 3, Interventional, and Other
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 500 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Topcon Medical Systems, Inc. is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
All eyes to be treated with riboflavin and UV light
Drug: Riboflavin · Device: VEGA UV-A Illumination System
Riboflavin is a solution that will be delivered to the treatment area
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
Changes in Corneal Curvature
Time frame: 24 MO
The recruitment period started December 2010 and ended June 2012 at medical clinics throughout the country.
| Milestone | CXL Treatment |
|---|---|
| Started | 372 |
| Completed | 0 |
| Not completed | 372 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CXL Treatment | — | 0/372 (0%) | 0/372 (0%) |
| Age, Categorical(Participants) | CXL Treatment |
|---|---|
| <=18 years | NA |
| Between 18 and 65 years | NA |
| >=65 years | NA |
| Age, Continuous(years) | CXL Treatment |
|---|---|
| Mean | NA ± NA |
| Sex: Female, Male(Participants) | CXL Treatment |
|---|---|
| Female | NA |
| Male | NA |
| Region of Enrollment(participants) | CXL Treatment |
|---|---|
| United States | 372 |
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Topcon Medical Systems, Inc.