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CDR Elizabeth M. Hofmeister, MD* CDR Frank M. Bishop, MD* CAPT David J. Tanzer , MD**

Dose-response for Mitomycin -C in prevention of haze in photorefractive keratectomy for high myopia: Six month preliminary results. CDR Elizabeth M. Hofmeister, MD* CDR Frank M. Bishop, MD* CAPT David J. Tanzer , MD** Sandor Kaupp , MS* CAPT (ret) Steve Schallhorn , MD***

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CDR Elizabeth M. Hofmeister, MD* CDR Frank M. Bishop, MD* CAPT David J. Tanzer , MD**

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  1. Dose-response for Mitomycin-C in prevention of haze in photorefractive keratectomy for high myopia: Six month preliminary results CDR Elizabeth M. Hofmeister, MD* CDR Frank M. Bishop, MD* CAPT David J. Tanzer, MD** SandorKaupp, MS* CAPT (ret) Steve Schallhorn, MD*** Navy Refractive Surgery Center, San Diego Financial disclosures: * Dr. Hofmeister, Dr. Bishop, and Mr. Kaupp have no financial disclosures. ** Dr. Tanzer is affiliated with TLC Laser Center *** Dr. Schallhorn is a consultant for AMO

  2. Disclaimer • The views expressed in this presentation are the personal views of the authors and not the official views of the U.S. Navy or the Department of Defense.

  3. Purpose • To investigate the safety and efficacy of Mitomycin-C (MMC) 0.1 mg/ml in preventing haze after PRK for high myopia at three different dose durations: • one minute • thirty seconds • fifteen seconds

  4. Methods • Randomized, prospective, placebo controlled, masked trial. • Patient eligibility: • Patients were recruited from those who selected PRK independently and those who were deemed ineligible for LASIK due to an inadequate estimated residual beds thickness. • Mean spherical equivalent -4.50 to 8.00 and no more than 1 diopter of anisometropia • No medical contraindications for refractive surgery • Age > 21.

  5. Methods • Surgical methods: • Epithelial removal with rotating brush • VISX S4 platform, wavefront guided ablation profiles with iris registration • Following excimer laser ablation, the study eye was treated with Mitomycin-C (MMC) 0.1 mg/ml soaking a 6 mm circular sponge, the control eye was treated with a 6 mm sponge soaked with balanced salt solution. • A bandage contact lens was placed in both eyes, followed by topical gatifloxacin, topical ketorolac, and topical fluorometholone. • Fluorometholone prescribed in a two month tapering dose schedule. • The patient and providers doing post op checks are masked as to which eye received MMC. • Study data collected: • Preoperative and postoperative endothelial cell counts by confocal microscopy • Preoperative and postoperative refractive error • Preoperative and postoperative uncorrected and best corrected visual acuity • Postoperative haze scores using a five point scale (0-4)

  6. Methods: Study data • One year study: Data collected preoperativelyand at 1, 3, 6, and 12 months • Endothelial cell counts: confocal microscopy • Haze scores: 0, 1, 2, 3, 4 • Visual acuity/contrast acuity • Manifest refraction

  7. Results: Preoperative Characteristics

  8. Results: Haze scores A= 60 sec. B= 30 sec. C= 15 sec.

  9. Results: Endothelial Cell Counts A= 60 sec. B= 30 sec. C= 15 sec. Change in endothelial cell count One month counts Six month counts

  10. Study Conclusions • At six months follow-up, there was no difference in haze scores in eyes of high myopes that received mitomycin and those that didn’t. • Mitomycin-C had no effect on endothelial cell counts. • Final twelve month evaluations are pending.

  11. References • Carones F, Vigo L, Scandola E, Vacchini L. Evaluation of the prophylactic use of mitomycin-C to inhibit haze formation after photorefractive keratectomy. J Cataract Refract Surg 2002; 28: 2088-2095. • Muller LT, Candal EM, Epstein RJ, Dennis RF, Majmudar PA. Transepithelial phototherapeutic keratectomy/photorefractive keratectomy with adjunctive mitomycin-C for complicated LASIK flaps. J Cataract Refract Surg 2005; 31: 291-296. • Lee DH, Chung HS, Jeon YC, Boo SD, Yoon YD, Kim JG. Photorefractive keratectomy with intraoperativemitomycin-C application. J Cataract Refract Surg 2005; 31: 2293-2298. • Pfister RR. Permanent corneal edema resulting from the treatment of PTK corneal haze with mitomycin: a case report. Cornea 2004; 23: 744-747. • Chang SW. Early corneal edema following topical application of mitomycin-C. J Cataract Refract Surg 2004; 30: 1742-1750. • Raviv T, Majmudar PA, Dennis RF, Epstein RJ. Mytomycin-C for post-PRK corneal haze. J Cataract Refract Surg 2000; 26: 1105-1106.

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