Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Ophthalmology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 6/2/2017 |
| Start Date: | May 1, 2017 |
| End Date: | January 2018 |
| Contact: | John S Jarstad, MD |
| Email: | jarstadj@health.missouri.edu |
| Phone: | (573) 884-2876 |
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 the cornea's shape.
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 the cornea's shape.
Corneal ectasia as a complication from refractive (LASIK) surgery as well as keratoconus is
a slowly progressive condition that results in high patient morbidity. Treatment options aim
to stabilize the shape of the cornea using rigid contact lenses, surgical insertion of stiff
plastic intrastromal rings, corneal cross linking, and ultimately corneal transplant in
severe patients. The recently FDA approved "Dresden Protocol" involves painful cornea
scraping followed by application of concentrated Riboflavin, followed by immediate collagen
cross linking with UV light exposure which results in shortening and thickening of the
collagen fibrils, and therefore a stronger, stiffer cornea. Avedro has demonstrated an
average cornea flattening (K max reduction) of 1.4 diopters and 1.7diopters in two different
studies. The current cost of Avedro therapy is between $2500 -$3500 per treatment. This is
considered experimental at this time and therefore is not covered by any insurance.To spare
the patient the severe pain involved in the current procedure, and to avoid the high cost
(Avedro is not covered by any medical insurance), the investigator started 7 patients with
keratoconus from 2011-2015 in his private practice in Seattle on a trial of oral riboflavin
(100 mg or 400 mg daily) and 15 minutes of sunlight exposure daily. No adverse effects have
ever been reported with high-dose dietary riboflavin supplements. The results of this
preliminary trial are remarkable. During follow-up from 6 months to 5 years, all 7 patients
have had corneal stabilization and/or corneal flattening. One patient experienced flattening
of the cornea by 1.5 Diopters, comparable to the best results of the Avedro system. A
limited animal study is currently underway to document that corneal cross-linking occurs in
response to dietary riboflavin and UV exposure from the sun. This clinical study would
expand the promising preliminary findings to a larger sample size. 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 the cornea's shape.
a slowly progressive condition that results in high patient morbidity. Treatment options aim
to stabilize the shape of the cornea using rigid contact lenses, surgical insertion of stiff
plastic intrastromal rings, corneal cross linking, and ultimately corneal transplant in
severe patients. The recently FDA approved "Dresden Protocol" involves painful cornea
scraping followed by application of concentrated Riboflavin, followed by immediate collagen
cross linking with UV light exposure which results in shortening and thickening of the
collagen fibrils, and therefore a stronger, stiffer cornea. Avedro has demonstrated an
average cornea flattening (K max reduction) of 1.4 diopters and 1.7diopters in two different
studies. The current cost of Avedro therapy is between $2500 -$3500 per treatment. This is
considered experimental at this time and therefore is not covered by any insurance.To spare
the patient the severe pain involved in the current procedure, and to avoid the high cost
(Avedro is not covered by any medical insurance), the investigator started 7 patients with
keratoconus from 2011-2015 in his private practice in Seattle on a trial of oral riboflavin
(100 mg or 400 mg daily) and 15 minutes of sunlight exposure daily. No adverse effects have
ever been reported with high-dose dietary riboflavin supplements. The results of this
preliminary trial are remarkable. During follow-up from 6 months to 5 years, all 7 patients
have had corneal stabilization and/or corneal flattening. One patient experienced flattening
of the cornea by 1.5 Diopters, comparable to the best results of the Avedro system. A
limited animal study is currently underway to document that corneal cross-linking occurs in
response to dietary riboflavin and UV exposure from the sun. This clinical study would
expand the promising preliminary findings to a larger sample size. 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 the cornea's shape.
Inclusion Criteria:
- patients identified as having keratoconus or post refractive cornea ectasia with
astigmatism of 1.5 Diopters or greater.
Exclusion Criteria:
- Known sensitivity to riboflavin, sunlight.
- patients on medications with side effects of increased sunlight sensitivity should
discuss participation with their prescribing provider prior to participation
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University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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