BACKGROUND: Following excimer laser photorefractive keratectomy, patients experience significant ocular pain until corneal reepithelialization. Despite the use of cold compresses, bandage soft contact lenses, cycloplegics, narcotics, and topical corticosteroids, the pain has not been adequately controlled in many patients. METHODS: A randomized, double-masked, parallel-group study of diclofenac sodium 0.1% ophthalmic solution and its placebo vehicle was evaluated. Patients undergoing excimer myopic photorefractive keratectomy on their second eye were admitted overnight. Postoperative procedures included two drops of diclofenac or placebo immediately after surgery and then qid until reepithelialization, topical tobramycin (qid), 0.1% fluorometholone (q2h), cycloplegics, and a disposable soft contact lens. Thirty-two patients (diclofenac = 16, placebo = 16) were evaluated from +30 minutes to +96 hours by several types of questionnaires. RESULTS: Most patients who received placebo experienced pain, starting within 1 hour, peaking at 4 to 6 hours and lasting 36 to 48 hours. The diclofenac-treated patients rarely experienced the early peak in pain, had less pain overall until 72 hours postoperatively, and experienced significantly less photophobia and burning/stinging. Significantly fewer patients on diclofenac required oral narcotics. Three patients (diclofenac = 2, placebo = 1) developed corneal infiltrates, the etiology of which is not known. In a separate study we conducted, there was no difference in epithelial healing times between the diclofenac-treated eyes and those not receiving the drug. CONCLUSIONS:Diclofenac appears to significantly reduce the ocular pain following excimer photorefractive keratectomy.
RCT Entities:
BACKGROUND: Following excimer laser photorefractive keratectomy, patients experience significant ocular pain until corneal reepithelialization. Despite the use of cold compresses, bandage soft contact lenses, cycloplegics, narcotics, and topical corticosteroids, the pain has not been adequately controlled in many patients. METHODS: A randomized, double-masked, parallel-group study of diclofenac sodium 0.1% ophthalmic solution and its placebo vehicle was evaluated. Patients undergoing excimer myopic photorefractive keratectomy on their second eye were admitted overnight. Postoperative procedures included two drops of diclofenac or placebo immediately after surgery and then qid until reepithelialization, topical tobramycin (qid), 0.1% fluorometholone (q2h), cycloplegics, and a disposable soft contact lens. Thirty-two patients (diclofenac = 16, placebo = 16) were evaluated from +30 minutes to +96 hours by several types of questionnaires. RESULTS: Most patients who received placebo experienced pain, starting within 1 hour, peaking at 4 to 6 hours and lasting 36 to 48 hours. The diclofenac-treated patients rarely experienced the early peak in pain, had less pain overall until 72 hours postoperatively, and experienced significantly less photophobia and burning/stinging. Significantly fewer patients on diclofenac required oral narcotics. Three patients (diclofenac = 2, placebo = 1) developed corneal infiltrates, the etiology of which is not known. In a separate study we conducted, there was no difference in epithelial healing times between the diclofenac-treated eyes and those not receiving the drug. CONCLUSIONS:Diclofenac appears to significantly reduce the ocular pain following excimer photorefractive keratectomy.