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.