Evaluation of diclofenac sodium 0.1% ophthalmic solution in the treatment of ocular symptoms after bilateral radial keratotomy.
OBJECTIVE
Patients frequently have ocular pain, photophobia, foreign-body sensation, and burning/stinging after radial keratotomy. This study was a prospective, randomized, double-masked, multicenter, fellow-eye comparison of diclofenac sodium (Voltaren Ophthalmic, 0.1% solution) and placebo for controlling these ocular symptoms after bilateral radial keratotomy.


METHODS
Patients who were pain free in both eyes before surgery were randomly assigned to treatment with diclofenac sodium in one eye and placebo in the other. One drop of each masked trial medication was administered 30-60 min before surgery, 5 min and 6 h after surgery, at bedtime on the day of surgery, and four times daily for 2 additional days. Patients evaluated ocular symptoms in each eye 0.5, 1, 2, 4, 6, 24, and 48 h after surgery and provided a global evaluation 6, 24, and 48 h after surgery. For each assessment, the difference in scores between eyes was analyzed by using a paired t test.


RESULTS
Diclofenac sodium was significantly (p < 0.001) superior to placebo in controlling each ocular symptom at each interval after surgery and for patient global assessments 6, 24, and 48 h after surgery.


CONCLUSIONS
Diclofenac sodium 0.1% ophthalmic solution is clinically effective in controlling adverse ocular symptoms occurring after bilateral radial keratotomy.
Hettinger
M E
ME
Kansas City Eye Clinic, Overland Park, Kansas 66204-2622, USA.
Gill
D J
DJ
Robin
J B
JB
Levy
R H
RH
Koester
J
J
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007646:Keratotomy, Radial / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000601:surgery; D009883:Ophthalmic Solutions; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D014792:Visual Acuity
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D004008:Diclofenac