Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery.

PURPOSE: 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. DESIGN: Multicenter clinical study. PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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.

Efficacy and safety profile of ketorolac 0.5% ophthalmic solution in the prevention of surgically induced miosis during cataract surgery.

This multicenter, double-masked, randomized, parallel study compared the efficacy and safety profile of ketorolac tromethamine 0.5% ophthalmic solution with that of its vehicle in the maintenance of pupillary mydriasis during cataract surgery. A total of 176 adult patients scheduled to undergo unilateral extracapsular cataract extraction and posterior-chamber intraocular lens implantation received either ketorolac tromethamine 0.5% (n = 89) or vehicle (n = 87), starting 2 hours before surgery. One drop of study medication was instilled every 30 minutes for a total of 4 drops. No epinephrine was used in the intraoperative irrigating solution. Pupil diameter was measured with a caliper at 3 time points during surgery. To ensure participant safety, biomicroscopy, ophthalmoscopy, intraocular pressure, adverse events, and preoperative and postoperative visual acuity and refractive error were also monitored. The mean change in horizontal and vertical pupil diameter from the time of the first incision to after cortical irrigation and aspiration was significantly less with active ketorolac than with vehicle (P < or = 0.014). Consequently, mean pupil diameter after cortical irrigation and aspiration was significantly greater with ketorolac than with vehicle (P < or = 0.030). No significant between-group differences were observed in the change in pupil diameter between the end of surgery and postoperative administration of a miotic agent, safety variables, or occurrence of adverse events. In this study, ketorolac tromethamine 0.5% ophthalmic solution provided effective and well-tolerated inhibition of surgically induced miosis during cataract surgery.

Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial.

PURPOSE: To investigate the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution (Acular; Allergan, Inc, Irvine, California) in the treatment of moderate to severe anterior segment inflammation developing after unilateral cataract surgery with intraocular lens implantation. METHODS: Only patients who exhibited moderate or greater levels of cells and flare 1 day after surgery were included in this multicenter, double-masked, randomly assigned, parallel-group study. Topical ketorolac or vehicle solution (Allergan, Inc) was administered to the treated eye four times daily, starting the day after surgery and continuing for 14 days. RESULTS: Ketorolac was significantly more effective than the vehicle solution in reducing anterior chamber cells (P < or = .030) and flare (P < or = .025), conjunctival erythema (P < or = .046), ciliary flush (P < or = .006), tearing (P < or = .012), photophobia (P < or = .014), and pain (P < or = .049). Half as many patients from the ketorolac group (14/51) were discontinued from the study for lack of efficacy, compared with the vehicle group (28/51; P = .005). There was no significant difference between ketorolac and the vehicle solution in changes in visual acuity, intraocular pressure, biomicroscopic or ophthalmoscopic variables, or adverse events. CONCLUSIONS: Ketorolac tromethamine 0.5% ophthalmic solution is safe and provides substantial anti-inflammatory activity in the treatment of moderate to severe anterior segment inflammation developing after cataract surgery and intraocular lens implantation.

Efficacy and safety of nonpreserved ketorolac ophthalmic solution in postoperative ocular pain following radial keratotomy.

PURPOSE: To investigate the efficacy and safety of nonpreserved ketorolac tromethamine 0.5% ophthalmic solution in relieving pain following radial keratotomy (RK). SETTING: Multicenter clinical trial. METHODS: Topical ketorolac was compared with its vehicle in a double-masked, randomized, parallel-group study involving 170 RK patients. Patients were treated with nonpreserved ketorolac 0.5% ophthalmic solution or the vehicle 4 times daily beginning immediately after surgery and continuing for 3 days or until they no longer had ocular pain. RESULTS: At several intervals, patients treated with ketorolac reported significantly greater pain relief and less pain intensity than patients treated with the vehicle. The time required for patients to first report "complete relief" or "no pain" was shorter in the ketorolac than in the vehicle group (P < or = .006). Patients in the ketorolac group used less escape medication (acetaminophen) (P < or = .001) and had fewer sleep difficulties (P < or = .031), fewer symptoms of ocular discomfort (P < or = .028), and less difficulty performing activities of daily living (P = .048). Patients treated with ketorolac experienced the same low rate of treatment-related adverse events as those treated with the vehicle and exhibited the same improvement in visual acuity and manifest refraction. CONCLUSIONS: Nonpreserved ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than, and as safe as, the vehicle in alleviating the postoperative pain associated with RK. This resulted in significant improvements in patient quality of life and less need for oral analgesics, suggesting that topical ketorolac is an appropriate treatment option for ocular pain following RK.

Effect of topical anti-inflammatory treatment on the outcome of laser trabeculoplasty. The Fluorometholone-Laser Trabeculoplasty Study Group.

PURPOSE: We investigated the effect of anti-inflammatory treatment on the outcome of argon laser trabeculoplasty. METHODS: In this multicenter, double-masked, randomized, placebo-controlled, parallel comparison study, 140 chronic open-angle glaucoma patients received either 0.25% fluorometholone or vehicle four times a day unilaterally, beginning 24 hours before and continuing one week after argon laser trabeculoplasty. The laser surgeon placed 50 to 60 burns over the inferior 180 degrees of the trabecular meshwork. The patients were followed up frequently for five weeks after the procedure. RESULTS: Following argon laser trabeculoplasty, signs of anterior chamber inflammation were significantly lower in the fluorometholone group. However, there was no significant difference between the fluorometholone and the vehicle groups in the incidence of increased intraocular pressure in the immediate post-argon laser trabeculoplasty period. Intraocular pressure decreased significantly in both groups from day 1 throughout the follow-up period. A significant between-group difference in intraocular pressure decrease was found only at week 5 (7.83 +/- 6.27 [S.D.] mm Hg for the fluorometholone group vs 6.63 +/- 5.79 mm Hg for the vehicle group, P = .046). No drug-related clinically significant adverse events were observed. CONCLUSIONS: Use of fluorometholone is effective in attenuating inflammation and has no clinically significant impact on the outcome of argon laser trabeculoplasty or on the incidence of intraocular pressure spikes during the immediate post-argon laser trabeculoplasty period.

Intraocular availability and pupillary effect of flurbiprofen and indomethacin during cataract surgery.

PURPOSE: To compare the bioavailability and pupillary effect of flurbiprofen and indomethacin during phacoemulsification and intraocular lens implantation. SETTING: Gimbel Eye Centre, Calgary, Alberta, Canada. METHODS: In this prospective, randomized, double-masked study, 236 patients had cataract extraction by phacoemulsification and posterior chamber intraocular lens implantation. They received topical flurbiprofen 0.03% solution or indomethacin 1% suspension applied every 15 minutes for 60 to 75 minutes before surgery. An aqueous humor sample (100 microL) was taken immediately before the corneal incision was made. Pupil diameters (horizontal and vertical) were measured before aqueous humor sampling, after phacoemulsification, after irrigation and aspiration (I/A), and after acetylcholine instillation. RESULTS: Mean concentration of flurbiprofen and indomethacin in the aqueous humor was 59.8 ng/mL and 90.2 ng/mL, respectively (P < .001). The percentage of dose detected in the aqueous humor was 4.38% in the flurbiprofen group and 0.21% in the indomethacin group (P < .001). Pupil diameters were 7.2 and 7.3 mm presurgery and 7.0 and 7.0 mm after I/A in the flurbiprofen and indomethacin groups, respectively (P > .05). No adverse events were reported in either group. CONCLUSIONS: Although the absolute concentration of indomethacin was higher, the percentage of dose detected in the aqueous humor was 20 times greater in the flurbiprofen than in the indomethacin group. Flurbiprofen is absorbed 20 times more readily than indomethacin. Both drugs were equally effective in preventing miosis during cataract surgery.

Effects of flurbiprofen and indomethacin on acute cystoid macular edema after cataract surgery: functional vision and contrast sensitivity.

We examined the effect of acute cystoid macular edema (CME) on contrast sensitivity. Eyedrops were instilled into the surgically treated eye f1p4 times daily for two days preoperatively and for three months postoperatively. Angiographic and clinical CME were measured, as were contrast sensitivity and Snellen acuity. Jaeger visual acuity equivalents were calculated and digital imaging techniques used to simulate visual function. We found that angiographic CME reduces functional vision as measured by contrast sensitivity and visual acuity over a large range of sizes. In patients treated with the flurbiprofen vehicle, those without CME had higher mean contrast sensitivity scores than those with CME; this increased over time. Those treated with flurbiprofen and indomethacin had slightly higher contrast sensitivity scores than vehicle-treated patients; this also increased over time, most notably in the higher spatial frequencies. Flurbiprofen treatment improved contrast sensitivity in patients with and without CME significantly at 12 cycles per degree. Flurbiprofen-treated patients with CME in general had higher contrast sensitivity scores than vehicle-treated patients. In this population of patients having cataract surgery, treatment with flurbiprofen or indomethacin reduced the loss of functional vision associated with CME.

Ocufen (flurbiprofen) in the treatment of ocular pain after radial keratotomy.

Ocular pain is often treated with systemic analgesics, which are associated with some undesirable side effects. Because nonsteroidal anti-inflammatory drugs are thought to be peripheral analgesics, we decided to evaluate the local analgesic effect of flurbiprofen. After an initial study in 29 patients demonstrated that 0.03% flurbiprofen ophthalmic solution did not affect corneal sensitivity, a second trial was designed to test the analgesic efficacy and safety of this agent. In a multicenter, randomized, double-masked, parallel-group clinical trial, topically applied 0.03% flurbiprofen sodium ophthalmic solution was compared with its vehicle in 105 patients (53 females, 52 males) undergoing elective unilateral radial keratotomy. All patients received flurbiprofen or its vehicle before and every four hours after surgery for 14 days. Mean pain intensity variables were lower in the flurbiprofen group than the vehicle group after surgery. Clinically significant differences in pain relief (mean difference > or = 1 unit), favoring flurbiprofen, were seen at hours 2, 3, and 4, and on days 1 through 4, and on day 7. Statistically significant differences were seen at hours 2, 3, and 4. Sixteen patients (eight in each group) had adverse effects, most commonly transient burning. These studies suggest that topical 0.03% flurbiprofen safely and effectively relieves ocular pain without affecting corneal sensation.

Antimicrobial efficacy and aqueous humor concentration of preoperative and postoperative topical trimethoprim/polymyxin B sulfate versus tobramycin.

We compared trimethoprim sulfate 0.1%/polymyxin B sulfate 10,000 units/mL with tobramycin 0.3% for preoperative sterilization of the ocular surface, aqueous humor concentration, and ocular safety and comfort in 99 patients who had cataract extraction and intraocular lens implantation. The organisms most frequently cultured from the conjunctiva at baseline were Staphylococcus epidermidis, Corynebacterium species, and Staphylococcus aureus, which were isolated from 66%, 15%, and 8% of the 95 specimens eligible for evaluation. All organisms identified in positive baseline conjunctival cultures except Staphylococcus epidermidis were completely eradicated in both groups on the day of surgery and five to seven days postoperatively. Staphylococcus epidermidis was eradicated on the day of surgery in 58% of patients in the trimethoprim/polymyxin group and in 68% in the tobramycin group. This organism was eradicated five to seven days postoperatively in 85% of patients in both groups. Mean aqueous humor concentration of trimethoprim sulfate at surgery was greater than the mean tobramycin concentration, but neither reached clinically significant inhibitory levels for most organisms. No significant differences were found in ocular safety and comfort.

Ideal concentration of tropicamide with hydroxyamphetamine 1% for routine pupillary dilation.

In this double-masked clinical study, we evaluated four concentrations of tropicamide (0.05%, 0.1%, 0.25%, and 0.5%) combined with hydroxyamphetamine 1% to find the combination that gives maximal pupillary dilation and inhibition of responsiveness to light and minimal paralysis of accommodation. With all concentrations, pupil size was maximal at 60 minutes, and there was no significant difference between the groups in mean pupillary diameter. Inhibition of the pupillary responses to light and loss of accommodation were directly related to the concentration of tropicamide. Tropicamide 0.25% combined with hydroxyamphetamine 1% was considered ideal for dilation and inhibition of the light response without inhibiting accommodation for near vision.

Reduction of inflammation following cataract surgery by the nonsteroidal anti-inflammatory drug, flurbiprofen.

In this double-masked clinical trial, 72 patients undergoing cataract extraction surgery received a topical loading dose of 0.03% flurbiprofen or vehicle before surgery and one drop four times daily for 2 weeks after surgery. The severity of conjunctival hyperemia, aqueous humor cells, and aqueous humor flare was lower in the flurbiprofen-treated group than in the vehicle-treated group at all follow-up visits; the differences were significant on day 14. Four patients treated with flurbiprofen and two treated with vehicle exhibited postoperative hyphemas. Treatment with flurbiprofen appeared to decrease the severity of inflammation following cataract extraction surgery.

Prednisolone acetate-gentamicin combination following cataract surgery.

One-hundred-eleven patients participated in a 21-day, open-label study to evaluate the therapeutic efficacy and safety of a prednisolone acetate 1%-gentamicin 0.3% ophthalmic suspension to control inflammation and prevent infection after cataract surgery. Beginning the day after surgery, the medication was instilled qid for the next 21 days. No postoperative infection was noted, and postoperative inflammation, which was mild immediately after surgery, decreased steadily during follow-up. The results of this study suggest that a prednisolone acetate-gentamicin combination used for three weeks after cataract surgery is safe and has a positive therapeutic effect on postoperative inflammation and infection.