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NCT03095235 · ClinicalTrials.gov registry record · NA
Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking
A NA study, sponsored by University of Missouri-Columbia.
- Terminated
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03095235 is a NA study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 30 participants.
The verdict
NCT03095235, a NA study, was terminated before completion, sponsored by University of Missouri-Columbia.
- TERMINATED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Corneal ectasia is characterized by irregularity and thinning of the cornea, causing the cornea to bulge forward and cause distorted vision and impaired visual acuity. Corneal ectasia is a complication after refractive (LASIK) surgery. It is also the primary problem in keratoconus, a gradually progressive inherited condition that typically is manifested in young adulthood, more commonly in women. Treatment approaches to stabilize the cornea's shape include rigid contact lenses, surgical implantation of stiff plastic intrastromal corneal ring segments, a collagen cross-linking procedure and, in severe cases, cornea transplantation. The collagen cross-linking procedure involves topical application of a concentrated riboflavin (vitamin B2) solution after the corneal epithelium is scraped, followed by ultraviolet (UV) light exposure. UV light stimulates riboflavin to form new bonds (cross links) between the cornea's connective tissue, giving the cornea additional strength to maintain its shape and prevent the need for transplantation. The cost of one treatment using this system is $2,500 to $3,500. A small prospective study including 7 patients with keratoconus was started on a trial of oral riboflavin and 15 minutes of natural sunlight exposure daily. These patients reported no adverse effects and preliminary results showed corneal stabilization and/or corneal flattening in all 7 patients It is hypothesized that dietary riboflavin and natural sunlight is as effective in corneal crosslinking as the currently FDA approved Avedro therapy. If the clinical study confirms the investigators' early observations of the benefits of this approach, coupled with animal studies that document corneal cross-linking, the investigators will have data to pursue funding for larger clinical and animal studies. This has the potential to save millions of dollars in health care costs and ease the burden of treatment in patients who require therapy to induce corneal cross-linking to stabilize
Interventions
- DIETARY_SUPPLEMENT Dietary riboflavin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2021-03-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03095235
The ClinicalTrials.gov registry entry for NCT03095235 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dietary riboflavin is the first listed.
NCT03095235 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03095235 about?
NCT03095235 is a clinical study titled "Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking". Corneal ectasia is characterized by irregularity and thinning of the cornea, causing the cornea to bulge forward and cause distorted vision and impaired visual acuity. Corneal ectasia is a complication after refractive (LASIK) surgery. It is also the primary problem in keratoconus, a gradually progr...
What is the current status of trial NCT03095235?
This trial is currently terminated. It is a NA study. The enrollment target is 30 participants. The study started on 2017-05-01. Estimated completion is 2021-03-08.
What interventions are being tested in trial NCT03095235?
The interventions under investigation include: Dietary riboflavin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03095235?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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