Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery.
OBJECTIVE
To compare the efficacy and safety of ketorolac 0.5% ophthalmic solution with its vehicle in the treatment of ocular inflammation after cataract surgery and intraocular lens implantation.


METHODS
Multicenter clinical study.


METHODS
One hundred four patients were prospectively randomized, 52 patients in treatment group, 52 patients in control group.


METHODS
Patients received either ketorolac or vehicle four times daily in the operated eye for 14 days starting the day after surgery in a prospective, double-masked, randomized, parallel group study. Only patients with moderate or greater postoperative inflammation the day after surgery were enrolled.


METHODS
The main outcome measures include inflammation (cell, flare, ciliary flush), intraocular pressure and visual acuity.


RESULTS
Ketorolac was significantly more effective than vehicle in reducing the manifestations of postoperative ocular inflammation, including: anterior chamber cells (P: = 0.002) and flare (P: = 0.009), conjunctival erythema (P: = 0.010), ciliary flush (P: = 0.022), photophobia (P: = 0.027), and pain (P: = 0.043). Five times as many patients were dropped from the study for lack of efficacy from the vehicle group (22/52) than from the ketorolac group (4/52; P: = 0.001). Ketorolac was found to be equally as safe as vehicle in terms of adverse events, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables.


CONCLUSIONS
Ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than vehicle in the treatment of moderate or greater ocular inflammation following routine cataract surgery, while being as safe as vehicle.
Solomon
K D
KD
Department of Ophthalmology, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA.
Cheetham
J K
JK
DeGryse
R
R
Brint
S F
SF
Rosenthal
A
A
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000867:Anterior Chamber / Q000187:drug effects* / Q000473:pathology; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D007429:Intraocular Pressure; D020911:Ketorolac Tromethamine / Q000008:administration & dosage / Q000627:therapeutic use*; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D018918:Phacoemulsification / Q000009:adverse effects*; D011446:Prospective Studies; D012449:Safety; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D014792:Visual Acuity
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D020911:Ketorolac Tromethamine