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Background

UVA/riboflavin for infectious keratitis. Prospective randomized double blind trial. Early experience. Erik Letko, MD 1 ; Francis W. Price, MD 1 ; Carlindo Pereira, MD 1 ; Marianne O. Price, PhD 2 ; Amilia Schrier, MD 3 ; Stephen L. Trokel, MD 3

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Background

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  1. UVA/riboflavin for infectious keratitis. Prospective randomized double blind trial. Early experience. Erik Letko, MD1; Francis W. Price, MD1; Carlindo Pereira, MD1; Marianne O. Price, PhD2; Amilia Schrier, MD3; Stephen L. Trokel, MD3 1Price Vision Group, 2Cornea Research Foundation of America, Indianapolis, IN; 3Edward S. Harkness Institute, Columbia University College of Physicians and Surgeons, New York, NY

  2. Background • UVA • 320-400 nm • Damage to DNA/RNA • Disinfection of drinking water • Air/surface disinfection • Riboflavin (vit. B2) • Photosensitizer • Rapidly passing through lipid membranes • Intercalates with nucleic acids • In cornea protects deeper layers from UVA

  3. Background • Riboflavin/UVA  oxidation of nucleic acid residues  ROS  damage to RNA/DNA • Kills microorganisms • Used to sterilize blood products • Collagen crosslinking • Strengthens the cornea to prevent progression of ulceration • Inactivates white blood cells • ?Reduction of scarring

  4. UVA/riboflavin in vitro • Inactivates • Bacteria • S. epidermidis • S. aureus (including MRSA) • S. pneumoniae (drug resistant) • E. coli • P. aeruginosa (multidrug resistant) • Viruses • West Nile • Parvovirus (porcine) • HIV • Parasites • Trypanosoma cruzi • Leishmania • Malaria • Ineffective • Candida albicans (Martins et al, IOVS, 2008)

  5. Purpose • To compare efficacy of UVA/riboflavin application between two different durations of UVA light exposure in patients with infectious keratitis

  6. Methods • Prospective randomized double blind trial (ongoing) • Single site (Price Vision Group) • FDA approved physician sponsored IND

  7. Methods • Inclusion criteria • Subjects must be 18 years of age or older • Diagnosis of (presumed) infectious keratitis • Corneal scraping sent for cultures and sensitivities • Exclusion criteria • Descemetocele or perforated cornea • Breastfeeding or pregnant women • Immunocompromised status

  8. Treatment protocol • Remove epithelium (if needed) • Saturate cornea with riboflavin (0.1% in 20% dextran) • UVA light at 365 nm (3 mW/cm2) (15 or 30 minutes) • Routine antibiotics after UVA/riboflavin application

  9. Results Pt - patient, epi - epithelial, *UVA light aperture PK - penetrating keratoplasty, Mor - Moraxella, Bac - Bacillus (non-anthracis), DSAEK - Descemet’s stripping endothelial keratoplasty, CL - contact lens, Acnt - Acanthamoeba, **patient currently followed

  10. Pt 1 - Day 0

  11. Pt 1 - Day 1

  12. Pt 1 - Day 5

  13. Pt 1 - Day 6

  14. Pt 1 - Day 21 - repeat UVA/riboflavin

  15. Pt 1 - Day 1/22

  16. Pt 1 - Day 5/26

  17. Pt 1 - Day 7/28

  18. Pt 1 - Day 17/38

  19. Pt 3 - Day 0

  20. Pt 3 - Day 2

  21. Pt 3 - Day 5

  22. Pt 3 - Day 6

  23. Pt 3 - Day 8

  24. Pt 5 - Day 0

  25. Pt 5 - Day 0

  26. Pt 5 - Day 11

  27. Conclusions • Application of UVA/riboflavin appears to be safe and might be effective for treatment of infectious keratitis • Longer or repeat treatments might be needed at least in some cases • Further investigation is warranted

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