topical cyclosporine for postoperative use in prk and lasik: preliminary results lcdr david d....
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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• CDR David Beverly MD• Donna Murdoch PhD• Sandy Kaupp MS• Neil Kelly PhD• 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-18C taking off from USS Nimitz
Topical Cyclosporine for Postoperative Use in PRK & LASIK: Study Design
100 LASIK
50 Standard Treatment
50 Standard Treatment+ Cyclosporine A 3 months Postop
11 in Follow up
11 in Follow up
100 PRK
50 Standard Treatment
50 Standard Treatment
+ Cyclosporine A3 months Postop
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
(WaveScan
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 UCVACurrent ef f ec t: F(2, 208)=3.2941, p=.03905
V ertic al bars denote 0.95 c onf idenc e interv als
Cyclosporine , Ye s Cyclosporine , No
PR K
1 d
ay U
C
1 w
eek
UC
1 m
on
th U
C
-0.3
-0.2
-0.1
0.0
0.1
0.2
0.3U
CV
A (
log
MA
R)
LASIK
1 d
ay U
C
1 w
eek
UC
1 m
on
th U
C
Cov ar iate means :W av eSc anTx SE: -2.55032
No significant difference in any group or interval
Preliminary Results: Postoperative Pain
Current ef f ec t: F(2, 206)=1.8632, p=.15778
V ertic al bars denote 0.95 c onf idenc e interv als
Cyclosporine , Ye s Cyclosporine , No
PRK
1 d
ay p
ain
1 w
eek
pai
n
1 m
on
th p
ain
-1
0
1
2
3
4p
ain
sco
re (
0-4)
LASIK
1 d
ay p
ain
1 w
eek
pai
n
1 m
on
th p
ain
Cov ar iate means :W av eSc anTx SE: -2.53333
No significant difference in LASIK
More immediate post op pain for PRK subjects getting topical Cyclosporine
Preliminary Results: Postoperative Tearing
Current ef f ec t: F(1, 119)=1.8872, p=.17210
V ertic al bars denote 0.95 c onf idenc e interv als
Cyclosporine , Ye s Cyclosporine , No
PR K
1 day te ar ing1 w e e k te ar ing
-1
0
1
2
3
4
tear
ing
sco
re (
0-4)
LASIK
1 day te ar ing1 w e e k te ar ing
Cov ar iate means :W av eSc anTx SE: -2.57851
No significant difference
Preliminary Results:Photophobia
Current ef f ec t: F(2, 202)=1.5111, p=.22316
V ertic al bars denote 0.95 c onf idenc e interv als
Cyclosporine , Ye s Cyclosporine , No
PR K
1 d
ay p
ho
top
ho
bia
1 w
eek
ph
oto
ph
ob
ia
1 m
on
th p
ho
top
ho
bia
-1
0
1
2
3
4
ph
oto
ph
ob
ia s
core
(0-
4)
LASIK
1 d
ay p
ho
top
ho
bia
1 w
eek
ph
oto
ph
ob
ia
1 m
on
th p
ho
top
ho
bia
Cov ar iate means :W av eSc anTx SE: -2.55844
No difference in LASIK
More immediate post op photophobia for PRK subjects getting topical Cyclosporine
Preliminary Results: Change in Low Contrast Acuity at 1 Month Postop
Current ef f ec t: F(1, 94)=1.0667, p=.30434
V ertic al bars denote 0.95 c onf idenc e interv als
Cyclosporine , Ye s Cyclopsporine , No
PRK LASIK-0.1
0.0
0.1
0.21M
-pre
op
mes
op
ic 2
5%C
A (
log
MA
R)
Cov ar iate means :W av eSc anTx SE: -2.61061
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.