Safety and efficacy of cyclosporine 0.05% drops versus unpreserved artificial tears in dry-eye patients having laser in situ keratomileusis.
OBJECTIVE
To evaluate dry-eye signs, symptoms, and refractive outcomes in patients with dry-eye disease having laser in situ keratomileusis (LASIK).


METHODS
In this randomized parallel double-masked prospective clinical trial, 42 eyes of 21 myopic patients (mean spherical equivalent -4.3 diopters [D], range -1.00 to -10.63 D) with dry-eye disease were treated with unpreserved artificial tears or cyclosporine 0.05% ophthalmic emulsion twice a day beginning 1 month before LASIK. Treatment with the study drug was discontinued for 48 hours post surgery and then resumed for 3 additional months. Both groups used additional artificial tears as needed. Study visits occurred pretreatment (baseline), before surgery, and at 1 week and 1, 3, 6, and 12 months after surgery.


RESULTS
Statistically significant increases from baseline were found in Schirmer scores for artificial tears at 1 month (P = .036) and for cyclosporine 0.05% before surgery and 1 week, 1 month, and 6 months after surgery (P<.018). There were no significant differences from baseline or between groups in responses to the Ocular Surface Disease Index questionnaire or best corrected visual acuity (BCVA), nor were there significant between-group differences in superficial punctate keratitis or uncorrected visual acuity. Mean refractive spherical equivalent in cyclosporine-treated eyes was significantly closer to the intended target at 3 and 6 months after surgery than in artificial-tears-treated eyes (P = .007). A greater percentage of cyclosporine eyes was within +/-0.5 D of the refractive target 3 months after surgery than artificial tears eyes (P = .015).


CONCLUSIONS
Successful outcomes after LASIK were achieved for dry-eye disease patients. Treatment with cyclosporine 0.05% provided greater refractive predictability 3 and 6 months after surgery than unpreserved artificial tears.
Salib
George M
GM
Los Angeles, California 90640, USA. gsalibmd@yahoo.com
McDonald
Marguerite B
MB
Smolek
Michael
M
D000287:Administration, Topical; D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020731:Keratomileusis, Laser In Situ; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D011183:Postoperative Complications; D011310:Preservatives, Pharmaceutical; D011446:Prospective Studies; D012029:Refraction, Ocular / Q000502:physiology; D013666:Tears / Q000378:metabolism; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D016572:Cyclosporine