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Topical Cyclosporine for Postoperative use in PRK and LASIK

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Topical Cyclosporine for Postoperative use in PRK and LASIK Powered By Docstoc
					  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, PhD
•   CDR Elizabeth Hofmeister MD
•   CDR Frank Bishop MD              The views expressed in
•   CDR David Beverly MD             this presentation are those
•   Donna Murdoch PhD                of the authors and do not
•   Sandy Kaupp MS                   necessarily reflect the
                                     official policy or position of
•   Neil Kelly PhD                   the Department of the
•   Jim Newacheck OD                 Navy, Department of
•   Steve Toman OD                   Defense, or the United
•   Myah Mirzaoff BS                 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
                                F/A-18C taking off from USS Nimitz
  before and after PRK and
  LASIK
 Topical Cyclosporine for Postoperative
  Use in PRK & LASIK: Study Design
                100                                        100
               LASIK                                       PRK


                             50                                        50
       50            Standard Treatment          50            Standard Treatment
Standard Treatment    + Cyclosporine A    Standard Treatment    + Cyclosporine A
                      3 months Postop                           3 months Postop




     11 in                11 in                18 in                 19 in
   Follow up            Follow up            Follow up             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          PRK with          LASIK with        LASIK with
            cyclosporine      standard          cyclosporine      standard
                              treatment                           treatment

Gender      Male = 16         Male = 16         Male = 8          Male = 9
            Female = 3        Female = 2        Female = 3        Female = 2


Age         mean = 27.5       mean = 25.0       mean = 27.8       mean = 30.6
            SD = 4.6          SD = 2.8          SD = 5.0          SD = 5.3
            range = 22-37     range = 22-32     range = 23-39     range = 25-42

Treatment   mean = -2.79      mean = -2.36      mean = -2.77      mean = -2.27
(WaveScan   SD = 1.15         SD = 1.27         SD = 1.28         SD = 1.13
 MRSE)      range =           range =           range =           range =
             -0.75 to -5.71    -1.01 to -5.56    -1.15 to -6.39    -0.51 to -3.84
Preliminary Results: Postop UCVA
                                Current effect: F(2, 208)=3.2941, p=.03905                            Covariate means:
                           Vertical bars denote 0.95 confidence intervals                             WaveScanTx SE: -2.55032
                   0.3


                   0.2
   UCVA (logMAR)




                   0.1


                   0.0                                                                                           No significant
                                                                                                                 difference in any
                   -0.1                                                                                          group or interval

                   -0.2


                   -0.3
                                                   1 month UC




                                                                                         1 month UC
                          1 day UC



                                       1 week UC




                                                                1 day UC



                                                                             1 week UC

                                                                                                          Cyclosporine, Yes
                                                                                                          Cyclosporine, No
                                     PRK                                   LASIK
                                           Preliminary Results:
                                           Postoperative Pain
                                                          Current effect: F(2, 206)=1.8632, p=.15778                                     Covariate means:
                                                         Vertical bars denote 0.95 confidence intervals                                  WaveScanTx SE: -2.53333
                                      4


                                      3
                   pain score (0-4)




                                      2
More immediate                                                                                                                                     No significant
post op pain for                                                                                                                                   difference in
PRK subjects                          1
                                                                                                                                                   LASIK
getting topical
Cyclosporine                          0


                                      -1
                                            1 day pain



                                                                1 week pain




                                                                                             1 day pain



                                                                                                            1 week pain
                                                                              1 month pain




                                                                                                                          1 month pain
                                                                                                                                             Cyclosporine, Yes
                                                                                                                                             Cyclosporine, No
                                                              PRK                                         LASIK
                            Preliminary Results:
                           Postoperative Tearing
                                 Current effect: F(1, 119)=1.8872, p=.17210                    Covariate means:
                                Vertical bars denote 0.95 confidence intervals                 WaveScanTx SE: -2.57851

                      4



                      3
tearing score (0-4)




                      2
                                                                                                          No significant
                                                                                                          difference
                      1



                      0



                      -1
                           1 day tearing                     1 day tearing
                                           1 w eek tearing                   1 w eek tearing       Cyclosporine, Yes
                                                                                                   Cyclosporine, No
                                     PRK                               LASIK
                                                 Preliminary Results:
                                                    Photophobia
                                                                      Current effect: F(2, 202)=1.5111, p=.22316                                                                        Covariate means:
                                                                     Vertical bars denote 0.95 confidence intervals                                                                     WaveScanTx SE: -2.55844

                                            4
                  photophobia score (0-4)



More immediate                              3
post op
photophobia for                             2
PRK subjects
getting topical                             1
Cyclosporine
                                                                                                                                                                                           No difference
                                                                                                                                                                                           in LASIK
                                            0

                                            -1
                                                 1 day photophobia



                                                                            1 week photophobia




                                                                                                                       1 day photophobia



                                                                                                                                             1 week photophobia
                                                                                                 1 month photophobia




                                                                                                                                                                  1 month photophobia       Cyclosporine, Yes
                                                                                                                                                                                            Cyclosporine, No
                                                                          PRK                                                              LASIK
   Preliminary Results: Change in
Low Contrast Acuity at 1 Month Postop
                                              Current effect: F(1, 94)=1.0667, p=.30434      Covariate means:
                                            Vertical bars denote 0.95 confidence intervals   WaveScanTx SE: -2.61061

                                     0.2
   1M-preop mesopic 25%CA (logMAR)




                                     0.1

                                                                                                      No significant
                                                                                                      difference

                                     0.0




                                                                                                Cyclosporine, Yes
                                     -0.1                                                       Cyclopsporine, No
                                                    PRK                            LASIK
             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.

				
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posted:5/11/2013
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