Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies.

PURPOSE: To evaluate the efficacy and safety of phenylephrine 1.0%-ketorolac 0.3% (Omidria) for maintenance of mydriasis during, and reduction of ocular pain after, cataract surgery. SETTING: Twenty centers in the United States and the Netherlands. DESIGN: Prospective randomized clinical trials. METHODS: Patients having cataract surgery or refractive lens exchange were enrolled in 2 clinical trials. Phenylephrine 1.0%-ketorolac 0.3% or placebo was added to irrigation solution and administered intracamerally during the procedure. Integrated analyses of primary and secondary endpoints were conducted. RESULTS: The clinical trials comprised 808 patients (403 treatment and 405 placebo). Phenylephrine 1.0%-ketorolac 0.3% was superior to placebo for the maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. The mean area under the curve (AUC) change from baseline in pupil diameter was 0.08 mm for treatment compared with -0.50 mm for placebo (P < .0001). The mean AUC of ocular pain visual analog scale scores within 12 hours postoperatively was 4.16 mm for the treatment group and 9.06 mm for the placebo group (P < .001). Results of all secondary efficacy analyses demonstrated a significant treatment effect associated with phenylephrine 1.0%-ketorolac 0.3%. Treatment-emergent adverse events were as expected for a population having cataract surgery; no clinically significant differences in safety measures were observed between treatment groups. CONCLUSION: In this integrated analysis, phenylephrine 1.0%-ketorolac 0.3% administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis during the procedure and reducing postoperative ocular pain. FINANCIAL DISCLOSURE: Dr. Schaaf is an employee and holds an equity interest in Omeros Corporation. Drs. Hovanesian, Sheppard, Trattler, Gayton, and Ng are consultants to Omeros Corporation. No other author has a financial or proprietary interest in any material or method mentioned.

Implantation of multifocal intraocular lenses using a magnification strategy in cataractous eyes with age-related macular degeneration.

PURPOSE: To examine visual function after targeting -2.0 diopter (D) spherical equivalent (SE) when implanting a multifocal intraocular lens (IOL) in eyes with cataract and age-related macular degeneration (AMD). SETTING: Three private practices. DESIGN: Case series. METHODS: Lenses of cataractous eyes with AMD were replaced with the Acrysof Restor SN60D3 multifocal IOL, targeting an SE of -2.0 D, which yielded +5.2 D near addition. Near and distance visual acuities were examined. Patients completed a visual function questionnaire preoperatively and 6 months postoperatively. RESULTS: At 6 months, 13 patients with 20 eligible eyes were examined. The uncorrected near visual acuity improved in 18 eyes (90%) and was unchanged in 2 eyes. The corrected distance visual acuity improved in 14 eyes (70%), was unchanged in 4 eyes (20%), and decreased (≤ 3 lines) in 2 eyes (10%). All vision-related questionnaire items improved. CONCLUSION: For cataractous eyes with AMD, replacing the crystalline lens with this myopia-targeted multifocal IOL improved or maintained near vision without severely compromising distance vision. FINANCIAL DISCLOSURE: Drs. Mackool and Ernest are consultants to Alcon. Dr. Mackool is an inventor in the patent of the IOLs related to this strategy. No other author has a financial or proprietary interest in any material or method mentioned.

Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain.

PURPOSE: To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.09% dosed once daily for the treatment of ocular inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation. DESIGN: Randomized, double-masked, vehicle-controlled or active-controlled, multicenter, clinical trials. PARTICIPANTS AND CONTROLS: A total of 872 subjects (872 study eyes: bromfenac in 584, placebo in 288). METHODS: Four randomized, double-masked, vehicle or active-controlled, clinical trials were conducted at 134 ophthalmology clinics in the United States. Subjects aged ≥ 18 years were randomized to receive either bromfenac 0.09% or placebo dosed once daily beginning 1 day before cataract surgery (day -1), continuing on the day of surgery (day 0), and continuing for an additional postoperative 14 days. Subjects were evaluated for efficacy and safety on days 1, 3, 8, 15, and 22. The primary efficacy end point was cleared ocular inflammation, measured by the summed ocular inflammation score (SOIS; anterior chamber cells and flare) by day 15. The secondary efficacy end point was the number of subjects who were pain-free at day 1. The data from the 4 trials were pooled for analyses. MAIN OUTCOME MEASURES: The SOIS and ocular pain. RESULTS: The proportion of subjects who had cleared ocular inflammation by day 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The mean SOIS in the bromfenac 0.09% group was significantly lower than in the placebo group at days 3, 8, 15, and 22 (P < 0.0001). The proportion of subjects who were pain-free at days 1, 3, 8, and 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The incidence of adverse events reported in the bromfenac 0.09% group was significantly lower than in the placebo group (P < 0.0001). On day 15, 84.0% of the bromfenac subjects had ≥ 1-line improvement in visual acuity compared with 66.1% of placebo subjects (P < 0.0001). CONCLUSIONS: Bromfenac 0.09% dosed once daily was clinically safe and effective for reducing and treating ocular inflammation and pain associated with cataract surgery. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Clinical outcomes of complex and uncomplicated cataractous eyes after lens replacement with the AcrySof toric IOL.

PURPOSE: to compare outcomes for uncomplicated versus complex eyes after implantation of AcrySof toric intraocular lenses (IOLs) (Alcon Laboratories Inc) in a retrospective series of cataractous astigmatic eyes. METHODS: toric IOLs were implanted in 230 eyes of 162 adult patients. Approximately half (52%, n=120) the eyes had no complications (uncomplicated group). The other 110 (48%) eyes (complex group) had a variety of complexities, including retinal or macular problems (eg, age-related macular degeneration), angle or pressure problems (eg, glaucoma), or high astigmatism that required adjunctive limbal relaxing incisions (LRIs). Outcomes were retrospectively assessed approximately 6 weeks after surgery. RESULTS: preoperative corneal astigmatism was 1.60 ± 1.20 diopters (D) overall (1.40 ± 0.70 D in the uncomplicated group and 1.90 ± 1.60 D in the complex group). Residual cylinder was 0.40 ± 0.60 D overall (P<.01 compared to baseline) and was significantly lower (P<.01) for the uncomplicated group (0.30 ± 0.40 D) than for the complex group (0.50 ± 0.80 D), which contained the adjunctive LRI subgroup (residual cylinder 0.80 ± 0.70 D). A larger percentage of uncomplicated eyes (26%) than complex eyes (16%) had at least 20/20 uncorrected distance visual acuity (UDVA) (P=.05). Excluding eyes with intentionally targeted myopic postoperative spherical equivalent, no eyes lost Snellen lines of UDVA, and the average improvement in UDVA was 0.8 ± 0.6 logMAR. Corrected distance visual acuity of the retinal/macular subgroup was poorer than the uncomplicated group pre- and postoperatively but was significantly improved by the surgery (P<.001; average improvement approximately 3 Snellen lines). CONCLUSIONS: AcrySof toric IOLs reduced cylinder and improved UDVA in both complex and uncomplicated eyes with cataractous astigmatism.

Etiology, prevalence, and treatment of dry eye disease.

PURPOSE: This review article examines the prevalence, etiology, and current therapies of dry eye disease, with special focus on postmenopausal women. METHOD: A systematic literature search utilizing MEDLINE was conducted to identify peer-reviewed articles related to dry eye published prior to September 2008. The terms "dry eye" and "women" were searched in combination with one or more of the following words or phrases: prevalence, postmenopausal, etiology, risk factors, therapy, medications, surgery, tear film, and quality of life. Articles were selected based on their direct applicability to the subject matter. A manual search was also conducted based on citations in the published literature. RESULTS: Epidemiologic studies identified prevalence rates ranging from 7% in the United States to 33% in Taiwan and Japan. Risk factors include advanced age, female sex, smoking, extreme heat or cold weather conditions, low relative humidity, use of video display terminals, refractive surgery, contact lens wear, and certain medications. CONCLUSION: The last decade has brought about a better understanding of the etiology of dry eye disease. New therapies that can alleviate the signs and symptoms of dry eye disease and, consequently, improve the quality of life of dry eye patients are available in the market.

A clinical comparison of two different prednisolone acetate formulations in patients undergoing cataract surgery.

PURPOSE: This study was conducted to evaluate the efficacy of two topical steroid prednisolone preparations (Econopred Plus 1%, prednisolone acetate 1%: EPP; Pred Fortedagger 1%, prednisolone acetate 1%: PF) in reducing postoperative inflammation in cataract patients. METHODS: This was a 4 week, randomized, parallel-group, single-center, active-controlled study. One group of patients received postoperative topical EPP while the other group received postoperative topical PF. Both medications were dosed 4 times per day for 14 days and then BID until the container was empty. Both groups of patients received diclofenac sodium QID for 14 days and hydroxypropyl guar (HP-Guar, Systane) QID for 7 days then PRN (or as directed). The presence of corneal surface keratitis, anterior chamber cells and flare (scales 0-3 for keratitis, 0-5 for cells and 0-4 for flare; 0 = none) was evaluated by slit lamp biomicroscopy. RESULTS: EPP produced significantly lower (P < 0.05) anterior chamber flare scores 14 days following surgery (mean +/- SD: 0.86 +/- 0.53) than PF (1.08 +/- 0.40). Otherwise, there were no differences observed between the 2 treatments with respect to keratitis, anterior chamber flare or cells at postop days 1, 7, or 28. CONCLUSIONS: This comparative trial demonstrated that both formulations of prednisolone acetate 1% have similar efficacy in the treatment of postoperative ophthalmologic inflammation.

Analysis of elements of interlenticular opacification.

PURPOSE: To report the histopathologic and ultrastructural features of three cases of interlenticular opacification (ILO) between piggyback intraocular lenses. DESIGN: Interventional case series with clinicopathologic correlation. METHODS: Three pairs of acrylic piggyback lenses were explanted due to decrease in visual acuity associated with ILO. Lenses were evaluated with gross and light microscopic examinations in all cases. The anterior lens in one case was examined with scanning electron microscopy and energy dispersive x-ray spectroscopy. RESULTS: The material opacifying the interlenticular space was composed mostly of retained/regenerative cortical material in all cases. From the peripheral interface towards the central interface, the opacifying material changed as the interlenticular space was progressively narrower. The material attached to the peripheral interface, where the interlenticular space was wider, was very thick. At the midperipheral interface, the thick cortical material was broken into multiple globules due to liquefactive degeneration. At the paracentral zone, compression of the globules formed a flat, compact layer of an amorphous material. At the central interface (contact zone), almost no material could be found between the piggyback lenses. CONCLUSIONS: Analyses of ILO cases where all the components of the opacifying material were in situ allowed us to confirm that the pathogenesis of this complication is similar to that of posterior capsule opacification; thus, careful removal of lens epithelial cells and cortical material is mandatory in piggyback implantation.