Topical Cyclosporine for Postoperative use in PRK and

Topical Cyclosporine for Postoperative use in PRK and LASIK: Preliminary Results LCDR David D. Hessert, M. D. Ophthalmology Chief Resident Naval Medical Center San Diego The authors have no financial interest in the products or procedures discussed

Navy Refractive Surgery Center San Diego Research Team • • • CAPT David J. Tanzer MD LCDR Tyson Brunstetter OD, Ph. D CDR Elizabeth Hofmeister MD CDR Frank Bishop MD CDR David Beverly MD Donna Murdoch Ph. D Sandy Kaupp MS Neil Kelly Ph. D Jim Newacheck OD Steve Toman OD Myah Mirzaoff BS The views expressed in this presentation are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States Government.

Research Objectives • Determine whether topical cyclosporine A improves final visual performance following PRK & LASIK • Evaluate differences in the rate of improvement in uncorrected visual acuity for patients receiving topical cyclosporine or standard topical treatment before and after PRK and LASIK F/A-18 C taking off from USS Nimitz

Topical Cyclosporine for Postoperative Use in PRK & LASIK: Study Design 100 LASIK 100 PRK 50 Standard Treatment + Cyclosporine A 3 months Postop 11 in Follow up 18 in Follow up 19 in Follow up All numbers refer to subjects, both eyes of each subject are analyzed

Topical Cyclosporine for Postoperative Use in PRK & LASIK: Preliminary Analysis PRK with cyclosporine PRK with standard treatment LASIK with cyclosporine LASIK with standard treatment Gender Male = 16 Female = 3 Male = 16 Female = 2 Male = 8 Female = 3 Male = 9 Female = 2 Age mean = 27. 5 SD = 4. 6 range = 22 -37 mean = 25. 0 SD = 2. 8 range = 22 -32 mean = 27. 8 SD = 5. 0 range = 23 -39 mean = 30. 6 SD = 5. 3 range = 25 -42 Treatment (Wave. Scan MRSE) mean = -2. 79 SD = 1. 15 range = -0. 75 to -5. 71 mean = -2. 36 SD = 1. 27 range = -1. 01 to -5. 56 mean = -2. 77 SD = 1. 28 range = -1. 15 to -6. 39 mean = -2. 27 SD = 1. 13 range = -0. 51 to -3. 84

Preliminary Results: Postop UCVA No significant difference in any group or interval

Preliminary Results: Postoperative Pain More immediate post op pain for PRK subjects getting topical Cyclosporine No significant difference in LASIK

Preliminary Results: Postoperative Tearing No significant difference

Preliminary Results: Photophobia More immediate post op photophobia for PRK subjects getting topical Cyclosporine No difference in LASIK

Preliminary Results: Change in Low Contrast Acuity at 1 Month Postop No significant difference

Conclusions • Preliminary data does not demonstrate a benefit to topical Cyclosporine postoperatively for patients undergoing PRK or LASIK • Topical Cyclosporine is associated with increased postoperative pain and photophobia when used following PRK

References • • • Safety and Efficacy of Cyclosporine 0. 05% Drops Versus Unpreserved Artificial Tears in Dry-Eye Patients Having Laser In Situ Keratomileusis. Salib GM et al. J Cataract Refract Surg. 2006; 32: 772 -8. Effect of Cyclosporine A on Recovery of Visual Acuity Following LASIK. Ursea R et al. J refract Surg. 2007 The Effect of Tear Film and Ocular Surface Management on Myopic LASIK Outcomes. Albietz J et al. Adv Exp Med Biol. 2002; 506(pt A): 711 -7. Decrease in Tear Secretion and Corneal Sensitivity After Laser In Situ Keratomileusis. Benitez-del-Castillo JM et al. Cornea. 2001; 20(1): 30 -2. Two Multicenter, Randomized Studies of the Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in Moderate to Severe Dry Eye Disease. Sall K et al. Ophthalmology. 2000; 107(4): 631 -9.