To assess the corneal epithelial function after prolonged topical administration of diclofenac 0.1% and flurbiprofen 0.03% single-dose eyedrops.
University Eye Clinic of Trieste, Trieste, Italy.
This randomized prospective study comprised 24 patients scheduled for phacoemulsification. The patients were randomly assigned to receive diclofenac or flurbiprofen eyedrops for 2 months after surgery. Corneal epithelial permeability was determined by fluorophotometry 7, 37, and 67 days after surgery.
An increase in corneal epithelial permeability was observed in the diclofenac group 37 and 67 days after surgery. No epithelial function alterations occurred in the flurbiprofen group.
Subclinical impairment of the epithelial function was observed during topical treatment with diclofenac 0.1% single-dose eyedrops after phacoemulsification. The mechanism responsible for this effect remains unknown.
To compare the anti-inflammatory effect of diclofenac sodium 0.1% ophthalmic solution, flurbiprofen 0.03% ophthalmic solution, and indomethacin 1.0%.
Department of Ophthalmology, University of Köln, and Bundesknappschaftskrankenhaus, Sulzbach, Germany.
One hundred seventeen patients enrolled in this prospective, randomized, double-masked, and parallel-group study had phacoemulsification and intraocular lens implantation and received one of the three solutions. Preoperatively at day 1 and postoperatively at day 4 or 5 and day 12, 13, or 14, they were examined by slitlamp, applanation tonometry, and laser flare meter.
Anterior chamber flare reduction from baseline was significantly greater in the diclofenac group than in the flurbiprofen group (P = .022). Patients in the diclofenac group had significantly less burning and stinging than those in the flurbiprofen and indomethacin groups at postoperative days 4-5 and 12-14 (P = .001).
Diclofenac sodium appeared to be more potent than flurbiprofen in controlling intraocular inflammation after cataract surgery and appeared to be locally tolerated better than flurbiprofen and indomethacin.
We conducted a double-masked, vehicle-controlled study to evaluate the anti-inflammatory effect of topical flurbiprofen in cataract surgery by phacoemulsification and implantation of a posterior chamber intraocular lens. The 233 patients were randomized to receive either flurbiprofen or vehicle immediately prior to and for two weeks following surgery. No concomitant corticosteroid use was allowed. The flurbiprofen group had significantly less anterior chamber cells and flare at day 7 and significantly less conjunctival erythema, corneal edema, and lid edema at day 14. The investigator's global effectiveness rating was higher in the flurbiprofen group at day 14. Blood-aqueous barrier disruption, as measured by aqueous fluorophotometry, was statistically significantly diminished in the flurbiprofen group. Burning and stinging were rated significantly greater in the flurbiprofen group than in the vehicle group. Foreign-body sensation and photophobia were significantly more severe in the vehicle group than in the flurbiprofen group. Flurbiprofen provided postsurgical anti-inflammatory efficacy in clinical signs of inflammation and in blood-aqueous barrier disruption, and also showed improved subjective signs.
To assess the efficacy and safety of difluprednate ophthalmic emulsion 0.05% (Durezol) 2 or 4 times a day compared with those of a placebo in the treatment of inflammation and pain associated with ocular surgery.
Twenty-six clinics in the United States.
One day after unilateral ocular surgery, patients who had an anterior chamber cell grade of 2 or higher (>10 cells) were treated with 1 drop of difluprednate 2 times or 4 times a day or with a placebo (vehicle) 2 times or 4 times a day in the study eye for 14 days. This was followed by a 14-day tapering period and a 7-day safety evaluation. Outcome measures included cleared anterior chamber inflammation (grade 0, <or=1 cell), absence of pain, and analysis of ocular adverse events.
Of the 438 patients, 111 received difluprednate 2 times a day, 107 received difluprednate 4 times a day, and 220 received a placebo 2 or 4 times a day. Both difluprednate dosage regimens reduced postoperative ocular inflammation and pain safely and effectively compared with the placebo. A greater proportion of difluprednate-treated patients had a reduction in inflammation and pain at 8 days and 15 days. Three percent of patients in both difluprednate groups had a clinically significant IOP rise (>or=10 mm Hg and >or=21 mm Hg from baseline, respectively) versus 1% in the placebo group.
Difluprednate given 2 or 4 times a day cleared postoperative inflammation and reduced pain rapidly and effectively. There were no serious ocular adverse events. Fewer adverse events were reported in the difluprednate-treated groups than in the placebo group.
To compare the effects of topical cyclosporine A 0.05% (Restasis) with those of prednisolone acetate 1.00% (Pred Forte) on corneal haze after photorefractive keratectomy (PRK).
Gavin Herbert Eye Institute, University of California, Irvine-Orange, California, USA.
After -9.00 diopter PRK, 15 rabbits were divided into 3 groups and treated for 4 weeks with prednisolone acetate 1.00% or cyclosporine A 0.05% or neither (control). Corneal haze was measured by in vivo confocal microscopy preoperatively and 2, 4, 6, 8, and 12 weeks postoperatively. At 12 weeks, the corneas were evaluated for collagen organization by ex vivo 2-photon second-harmonic generation and stromal cell density.
Corneal haze was significantly less in the prednisolone acetate group than in the cyclosporine and control groups during the first 6 weeks postoperatively (P<.02). At 8 weeks, there was no significant difference between the 3 groups. There was no significant difference in haze between the cyclosporine and control groups at any time. The stroma was also significantly thinner in the prednisolone acetate group than in the other groups for the first 4 weeks postoperatively (P<.02). Second-harmonic generation scar thickness measurements at 12 weeks were not significantly different between the groups, although the prednisolone acetate group tended to have lower stromal cell density.
Cyclosporine A 0.05% had no effect on wound healing after PRK, while prednisolone acetate 1.00% significantly reduced peak corneal haze but had no effect on long-term corneal haze after discontinuation of the drug.
To evaluate the efficacy of cyclosporine 0.05% in alleviating dry-eye signs and improving visual quality after multifocal intraocular lens (IOL) implantation.
Private practice and university medical center, New York, New York, USA.
This randomized prospective contralaterally controlled double-masked trial comprised patients scheduled to have bilateral phacoemulsification with implantation of a refractive multifocal IOL (ReZoom). Patients received twice-daily cyclosporine 0.05% in 1 eye and an artificial tear in the other eye from 1 month before to 2 months after second-eye surgery. Outcomes were evaluated at baseline and 2 months after second-eye surgery.
The study enrolled 28 eyes of 14 patients. At baseline, there were no statistically significant between-group differences in outcome measures. Two months postoperatively, the cyclosporine group had significantly lower mean uncorrected distance visual acuity than the artificial tear group (0.11 logMAR +/- 0.03 [SD] [20/25 Snellen equivalent] versus 0.19 +/- 0.05 logMAR [20/30]; P = .045) as well as significantly lower mean corrected distance visual acuity (0.0 +/- 0.02 logMAR [20/20] versus 0.1 +/- 0.02 logMAR [20/25]; P = .005) and corneal staining scores (0.210 +/- 0.07 versus 0.645 +/- 0.18; P = .034). Treatment with cyclosporine 0.05% also improved contrast sensitivity, conjunctival staining, and tear breakup time. Significantly more patients preferred the eye treated with cyclosporine 0.05% to the eye treated with artificial tears (57.1% versus 14.3%; P = .007).
Cyclosporine 0.05% therapy reduced dry-eye signs and improved visual quality after multifocal IOL implantation.
No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.
To evaluate dry-eye signs, symptoms, and refractive outcomes in patients with dry-eye disease having laser in situ keratomileusis (LASIK).
In this randomized parallel double-masked prospective clinical trial, 42 eyes of 21 myopic patients (mean spherical equivalent -4.3 diopters [D], range -1.00 to -10.63 D) with dry-eye disease were treated with unpreserved artificial tears or cyclosporine 0.05% ophthalmic emulsion twice a day beginning 1 month before LASIK. Treatment with the study drug was discontinued for 48 hours post surgery and then resumed for 3 additional months. Both groups used additional artificial tears as needed. Study visits occurred pretreatment (baseline), before surgery, and at 1 week and 1, 3, 6, and 12 months after surgery.
Statistically significant increases from baseline were found in Schirmer scores for artificial tears at 1 month (P = .036) and for cyclosporine 0.05% before surgery and 1 week, 1 month, and 6 months after surgery (P<.018). There were no significant differences from baseline or between groups in responses to the Ocular Surface Disease Index questionnaire or best corrected visual acuity (BCVA), nor were there significant between-group differences in superficial punctate keratitis or uncorrected visual acuity. Mean refractive spherical equivalent in cyclosporine-treated eyes was significantly closer to the intended target at 3 and 6 months after surgery than in artificial-tears-treated eyes (P = .007). A greater percentage of cyclosporine eyes was within +/-0.5 D of the refractive target 3 months after surgery than artificial tears eyes (P = .015).
Successful outcomes after LASIK were achieved for dry-eye disease patients. Treatment with cyclosporine 0.05% provided greater refractive predictability 3 and 6 months after surgery than unpreserved artificial tears.
To compare aqueous drug concentrations and prostaglandin E(2) (PGE(2)) levels in patients treated with ketorolac 0.4% and bromfenac 0.09% at trough dosing.
Private practice, Wilkes-Barre, Pennsylvania, USA.
This single-center randomized investigator-masked clinical study comprised 56 patients having cataract surgery. Patients received 1 drop of ketorolac 0.4% or bromfenac 0.09% 6 hours and 12 hours preoperatively consistent with on-label dosing schedules. Aqueous humor was collected at the start of surgery and analyzed for concentrations of ketorolac and bromfenac using a reverse-phase high-performance liquid chromatography-mass spectroscopy system and for PGE(2) levels by competitive enzyme immunoassay.
The mean aqueous PGE(2) level was 204.2 pg/mL +/- 95.5 (SD) in patients treated with ketorolac 0.4% and 263.7 +/- 90.0 pg/mL in patients treated with bromfenac 0.09%, (P = .020). The mean aqueous concentration of ketorolac and bromfenac at trough dosing was 130.5 +/- 37.8 ng/mL and 6.2 +/- 3.1 ng/mL, respectively (P = .004).
Higher aqueous levels and greater PGE(2) inhibition were observed in cataract surgery patients treated with ketorolac 0.4% than in patients treated with bromfenac 0.09% at trough dosing. These findings suggest that ketorolac 0.4% administered 4 times a day may provide better control of prostaglandin-mediated inflammation than bromfenac 0.09% administered twice a day.
To assess delayed epithelialization and corneal haze related to nepafenac ophthalmic suspension 0.1% (Nevanac) use after photorefractive keratectomy (PRK).
Private practice, Beverly Hills, California, USA.
This retrospective comparative chart review comprised 69 eyes (44 patients) that were divided into 2 treatment groups that were not statistically significantly different in age or preoperative spherical equivalent. The nepafenac group consisted of 34 eyes (22 patients) that received nepafenac 0.1%, moxifloxacin, and fluorometholone postoperatively. The non-nepafenac group included 35 eyes (22 patients) that received moxifloxacin and fluorometholone only. Patients were seen between 1 day and 5 days postoperatively for evaluation of epithelial healing and haze formation. Delayed epithelialization was defined as healing after day 5. All patients were followed for haze formation for a minimum of 3 months.
Statistical analysis showed no difference between the nepafenac and non-nepafenac groups in delayed epithelialization (P = .61, chi-square test). Neither group had significant corneal haze.
Nepafenac did not appear to delay corneal epithelial healing or contribute to haze formation after PRK.
To compare the effect of topical ketorolac tromethamine 0.5% solution and topical diclofenac sodium 0.1% solution on the inhibition of surgically induced miosis.
Tertiary care teaching hospital in South India.
Fifty-one patients were prospectively randomized to receive ketorolac 0.5% or diclofenac 0.1% at 3 intervals preoperatively. Patients with diabetes mellitus, pseudoexfoliation, or local pupil abnormalities were excluded from the study. Mydriatics comprising homatropine 1% plus phenylephrine 10% were instilled in all patients 1 hour before the peribulbar block at 5 intervals. Horizontal pupil diameters were obtained at the beginning of surgery, after capsulotomy, after intraocular lens (IOL) implantation, and at the end of surgery.
The mean horizontal pupil diameter was 7.40 mm at the start of surgery in both groups. The ketorolac group showed a consistent trend toward larger pupil diameters at subsequent surgical intervals. Changes from baseline also indicated more significant inhibition of miosis in the ketorolac group.
Topical ketorolac was a more effective inhibitor of miosis than topical diclofenac during extracapsular cataract extraction and IOL implantation. It also provided a more stable mydriatic effect throughout surgery.
To assess the efficacy of a povidone-iodine 0.4%-dexamethasone 0.1% suspension against bacterial, fungal, and Acanthamoeba clinical isolates.
Bascom Palmer Eye Institute, McKnight Research Building, Miami, Florida, USA.
One hundred milliliters of 10(4) colony-forming units/mL of ocular isolates of methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, Serratia marcescens, Candida albicans, Fusarium solani, and Acanthamoeba castellanii were inoculated into 100 μL of a povidone-iodine 0.4%-dexamethasone 0.1% suspension in a 96-well microtiter plate incubated at room temperature. Organism viability was assessed at 15, 30, and 60 seconds by removing 10 μL aliquots and streaking onto a 5.0% sheep blood agar plate (fungi and bacteria) and agar-agar (Acanthamoeba) using a 0.001 calibrated loop. The plates were then incubated at 35 °C and monitored for up to 7 days. Isolates were inoculated into 200 μL of trypticase soy broth as controls. The number of colonies was counted and compared with controls to determine the kill rate.
A 99.9% kill was observed for MRSA, P aeruginosa, S marcescens, and C albicans after 15 seconds of exposure and for F solani after 60 seconds. Acanthamoeba castellanii cyst viability was not inhibited by exposure to the povidone-iodine and dexamethasone suspension. Organism growth was achieved on all control broth.
Povidone-iodine 0.4%-dexamethasone 0.1% suspension killed all bacterial and candida isolates within 15 seconds of exposure. It killed Fusarium isolates at 60 seconds but was ineffective against Acanthamoeba cysts.
Drs. Pelletier and Miller have no financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.
To compare the effectiveness of a topical nonsteroidal drug (diclofenac 0.1%) and a topical steroidal drug (betamethasone 0.1%) in preventing cystoid macular edema (CME) and blood-aqueous barrier (BAB) disruption after small-incision cataract surgery and foldable intraocular lens (IOL) implantation.
Shohzankai Medical Foundation Miyake Eye Hospital, Tokyo, Japan.
This multicenter interventional double-masked randomized study comprised 142 patients having phacoemulsification and foldable IOL implantation. Seventy-one patients were randomized to receive diclofenac eyedrops and 71, betamethasone eyedrops for 8 weeks postoperatively. The incidence and severity of CME were evaluated by fluorescein angiography. Blood-aqueous barrier disruption was determined by laser flare-cell photometry.
Of the patients, 63 were men and 79 were women. Five weeks after surgery, the incidence of fluorescein angiographic CME was lower in the diclofenac group (18.8%) than in the betamethasone group (58.0%) (P<.001). At 1 and 2 weeks, the amount of anterior chamber flare was statistically significantly less in the diclofenac group than in the betamethasone group (P<.05). At 8 weeks, intraocular pressure was statistically significantly higher in the betamethasone group (P = .0003).
Diclofenac was more effective than betamethasone in preventing angiographic CME and BAB disruption after small-incision cataract surgery. Thus, nonsteroidal antiinflammatory agents should be considered for routine treatment of eyes having cataract surgery.
To compare a topical nonsteroidal antiinflammatory drug (nepafenac 0.1%) and a topical steroidal antiinflammatory drug (fluorometholone 0.1% ) in preventing cystoid macular edema (CME) and blood-aqueous barrier (BAB) disruption after small-incision cataract extraction with foldable intraocular lens (IOL) implantation.
Shohzankai Medical Foundation, Miyake Eye Hospital, Nagoya, Japan.
Randomized double-masked single-center clinical trial.
Patients were randomized to receive nepafenac 0.1% eyedrops or fluorometholone 0.1% eyedrops for 5 weeks after phacoemulsification with foldable IOL implantation. The incidence and severity of CME were evaluated by fluorescein angiography, retinal foveal thickness on optical coherence tomography, and BAB disruption on laser flare-cell photometry.
Thirty patients received nepafenac and 29 patients, fluorometholone. Five weeks postoperatively, the incidence of fluorescein angiographic CME was significantly lower in the nepafenac group (14.3%) than in the fluorometholone group (81.5%) (P<.0001). The fovea was thinner in the nepafenac group than in the fluorometholone group at 2 weeks (P=.0266) and 5 weeks (P=.0055). At 1, 2, and 5 weeks, anterior chamber flare was significantly less in the nepafenac group than in the fluorometholone group (P<.0001, P<.0001, and P=.0304, respectively). The visual acuity recovery from baseline was significantly greater in the nepafenac group (80.0%) than in the fluorometholone group (55.2%) (P=.0395). There were no serious side effects in either group.
Nepafenac was more effective than fluorometholone in preventing angiographic CME and BAB disruption, and results indicate nepafenac leads to more rapid visual recovery.
To determine whether nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation.
Twenty-one ophthalmology clinics in the United States.
A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score = 0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores.
The mean age of the 476 patients (243 nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the nepafenac group and 40 (17.2%) in the vehicle group were cured (P<.0001). A higher percentage of patients in the nepafenac group was pain free at all visits (P<.0001). Throughout the study, most nepafenac-treated patients were pain free (83.1% to 93.0%) compared with less than half the vehicle-treated patients (41.6% to 46.4%). The nepafenac group had lower mean aqueous cells, flare, and cells plus flare scores at all visits (P<.0001). No treatment-related ocular adverse events occurred in either group.
Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.
To compare the clinical, subjective, and objective outcomes of the use of 2 topical nonsteroidal antiinflammatory drugs--ketorolac tromethamine LS 0.4% (Acular) and nepafenac 0.1% (Nevanac)--in patients having cataract surgery.
Single-center private practice, Las Vegas, Nevada, USA.
One hundred eighty-three patients (193 eyes) with visually significant cataract were recruited for the study. Consenting patients were randomized to a standard regimen of Acular, gatifloxacin 0.3% (Zymar), and prednisolone acetate 1% (Pred Forte) (ketorolac group) or Nevanac, moxifloxacin hydrochloride 0.5% (Vigamox), and prednisolone acetate (Econopred) (nepafenac group). Analysis included subjective complaints (burning, itching, foreign-body sensation, pain level after surgery) and objective findings (visual function, degree of inflammation in the anterior segment, complications).
The ketorolac group consisted of 94 patients (100 eyes) and the nepafenac group, 89 patients (93 eyes). The between-group differences in visual outcomes and anterior chamber inflammation were not statistically significant (mean P = .33). There was a higher incidence of posterior capsule opacification in the nepafenac group (P = 0.019). Patient satisfaction, patient compliance, and postoperative pain control were statistically significantly better in the ketorolac group (P = .022, P = .023, and P = .025, respectively).
Ketorolac tromethamine was statistically significantly better than nepafenac in terms of patient satisfaction, compliance, and postoperative pain control.
To study the efficacy of combined diclofenac 0.1% and gentamicin 0.3% (Digen) eyedrops to treat postoperative inflammation and prevent ocular infection in eyes having phacoemulsification.
Department of Ophthalmology, University of Milan, San Paolo Hospital, Milan; Eye Clinic, University of Verona; and Department of Ophthalmology, University of Palermo, Italy.
This double-masked, randomized, clinical trial comprised 90 patients; 45 received Digen and 45, gentamicin 0.3% eyedrops. The main outcome measure of the study was the reduction in signs and symptoms of inflammation, graded on a four-point scale. Also assessed were the presence of bacteria in the conjunctival swab and the proportion of patients requiring additional medication.
Digen was more effective in reducing postoperative inflammation than gentamicin alone (P < .01). No statistically significant between-group difference was found regarding antibacterial activity. Both treatments were well tolerated throughout the study.
Digen seemed to maintain the properties and activities of each individual drug, making it a promising treatment for reducing inflammation after phacoemulsification.
To evaluate the effect of brimonidine tartrate 0.10% ophthalmic solution on pupil diameter under light and dark luminance conditions.
Ophthalmology Department, Tel Aviv Medical Center, Tel Aviv, Israel.
The pupil diameter was measured with a Colvard pupillometer in eyes of healthy volunteers under light (5.0 candelas [cd]/m(2)) and dark (0.0 cd/m(2)) luminance conditions before brimonidine 0.10% instillation and after 30 minutes, 3 hours, and 6 hours.
The mean age of the 26 volunteers (52 eyes) was 34.73 years (range 19 to 60 years). Under light conditions, the mean pupil diameter was 4.98 mm ± 0.83 (SD) before instillation of brimonidine 0.10% and 4.64 ± 0.82 mm after instillation. The difference was not statistically significant, with 13.4% of eyes having a clinically significant reduction (>1.0 mm) in pupil diameter after 6 hours. Under dark conditions, the mean pupil diameter was 6.76 ± 1.08 mm before instillation of brimonidine 0.10% and 5.30 ± 0.85 mm after instillation; the difference was statistically significant (P<.001). There was a clinically significant reduction in pupil diameter after 6 hours in 90.4% of eyes. The antimydriatic effect under dark luminance conditions was more pronounced in eyes with light irides.
Brimonidine 0.10% ophthalmic solution had an antimydriatic effect under dark luminance conditions and had a negligible effect on pupil diameter under light luminance conditions. The effect was similar to that reported in studies using higher concentrations of brimonidine.
To evaluate the efficacy of brimonidine tartrate ophthalmic solution 0.15% in patients with night-vision difficulties after laser refractive surgery.
Center for Refractive Surgery, Walter Reed Army Medical Center, Washington, District of Columbia, USA.
Six patients with significant night-vision complaints after refractive surgery were enrolled in this study after other treatable causes of night-vision difficulty such as residual refractive error and dry eye were excluded. Low-contrast visual acuity (LCVA) over a range of contrasts (1.25% to 25%) and small letter contrast sensitivity were tested at photopic (100 cd/m(2)) and mesopic (1 cd/m(2)) luminance levels, with and without a standard glare source. Testing was performed before brimonidine tartrate ophthalmic solution 0.15% was administered. Measurements were repeated 1 hour and 1 month after the use of brimonidine tartrate.
One hour after using brimonidine tartrate 0.15% solution, patients had significant improvement in LCVA, LCVA with glare, and contrast sensitivity. After 1 month of treatment, all 6 patients reported subjective improvement in night vision and there was a significant difference in performance in mesopic LCVA and mesopic LCVA with glare. The mean pupil size before administration of brimonidine tartrate ophthalmic solution 0.15% was 6.44 mm +/- 1.11 (SD). Pupil size 1 hour after instillation had decreased to 4.53 +/- 1.27 mm and at 1 month had increased to 6.50 +/- 0.94 mm.
Brimonidine tartrate ophthalmic solution 0.15% improved contrast sensitivity and acuity and decreased night-vision difficulty for up to 1 month in patients with significant complaints after refractive surgery.
To compare the efficacy and safety of brimonidine 0.15% with those of apraclonidine 0.5% in preventing intraocular pressure (IOP) elevations after anterior segment laser surgery.
Massachusetts Eye and Ear Infirmary, Glaucoma Service, Boston, Massachusetts, USA.
This double-masked randomized trial 80 eyes of 80 patients who had laser peripheral iridotomy, argon laser trabeculoplasty, or neodymium:YAG laser capsulotomy. Eyes received 1 drop of brimonidine 0.15% or apraclonidine 0.5% before laser surgery. Intraocular pressure, heart rate, and blood pressure were measured before laser surgery and at 1 hour, 3 hours, 24 hours, and 1 week after laser surgery.
Before laser treatment, 41 patients received brimonidine 0.15% and 39 received apraclonidine 0.5%. Thirteen (31.7%) patients in the brimonidine group and 11 (28.2%) in the apraclonidine group had postoperative IOP elevations of 5 mm Hg or more (P = .5). Four patients (9.8%) in the brimonidine group and 3 (7.7%) in the apraclonidine group had IOP increases of 10 mm Hg or more (P = .5). There were no statistically significant changes in mean heart rate or blood pressure in either group except a slight reduction in diastolic blood pressure at 1 hour in the brimonidine group (-4.7 +/- 9.2 mm Hg) compared with that in the apraclonidine group (-0.1 +/- 9.1 mm Hg) (P = .01). No clinically significant side effects were noted in either group.
A single preoperative drop of brimonidine 0.15% had similar efficacy and safety as apraclonidine 0.5% in preventing IOP elevations immediately after anterior segment laser surgery.
To evaluate the effect of brimonidine tartrate 0.15% ophthalmic solution (Alphagan P) on pupil diameter in eyes of healthy adults under different luminance conditions.
Center for Refractive Surgery, Ophthalmology Service, Department of Surgery, Walter Reed Army Medical Center, Washington, DC, USA.
Using a Colvard pupillometer, the pupil diameter was measured in 15 eyes of 15 healthy adults under 3 luminance conditions (scotopic, mesopic, photopic). The luminance of the room was measured using the Minolta LS-110 Luminance Meter. Pupil diameter was remeasured using the same technique 30 minutes, 4 hours, and 6 hours after administration of 1 drop of brimonidine tartrate 0.15% ophthalmic solution.
Under scotopic conditions (luminance 0.0 candelas [cd]/m(2)), the pupil diameter decreased by 1.0 mm or more in 100%, 87%, and 60% of eyes at 30 minutes, 4 hours, and 6 hours, respectively (P<.005); under mesopic conditions (luminance 0.2 cd/m(2)), in 93%, 73%, and 40% of eyes, respectively (P<.005); and under photopic conditions (luminance 150.2 cd/m(2)), in 73%, 87%, and 67% of eyes, respectively (P<.005).
Brimonidine tartrate 0.15% ophthalmic solution produced a significant miotic effect under all 3 luminance conditions. The reproducible miotic effect under scotopic and mesopic conditions may help postoperative refractive patients who report night-vision difficulties related to a large pupil.
To compare the effectiveness of brinzolamide 1% (Azopt) and brimonidine 0.2% (Alphagan) with a placebo in preventing an early increase in intraocular pressure (IOP) after phacoemulsification.
Department of Ophthalmology, Baskent University, School of Medicine, Ankara, Turkey.
In this prospective double-masked study, 90 eyes of 90 patients having clear corneal phacoemulsification were randomly divided into 3 groups of 30 eyes each. One hour before surgery, 1 group received 1 drop of brinzolamide 1%, another received 1 drop of brimonidine 0.2%, and the third received 1 drop of a balanced saline solution (placebo). The IOP was measured preoperatively and 3 and 16 to 20 hours postoperatively.
Three hours postoperatively, the mean IOP increased by 4.2 mm Hg +/- 7.0 (SD), 3.2 +/- 6.4 mm Hg, and 5.3 +/- 4.2 mm Hg in the brinzolamide, brimonidine, and placebo groups, respectively. The IOP increase from baseline was significant in all 3 groups (all P<.01), with no difference between the groups (P>.05). The change in IOP at 16 to 20 hours was 0.2 +/- 2.8 mm Hg, 0.2 +/- 2.4 mm Hg, and -0.8 +/- 2.4 mm Hg, respectively. The changes were not significant compared to baseline (all P>.05). Six eyes (20%) in the brinzolamide group, 5 eyes (16.7%) in the brimonidine group, and 7 eyes (23.3%) in the placebo group had an IOP higher than 25 mm Hg 3 hours postoperatively; the difference between groups was not significant (P =.8).
Prophylactic use of 1 drop of brinzolamide or brimonidine was not more effective than a placebo in controlling early postoperative IOP elevations after clear corneal phacoemulsification.
To quantitatively evaluate the effect of brimonidine tartrate 0.2% (Alphagan) on halo and pupil size in patients who had symptomatic night-vision difficulties after laser in situ keratomileusis (LASIK).
Nune Eye Hospital, Seoul, Korea.
This study comprised 28 eyes of 14 patients with symptomatic night-vision difficulties after LASIK. Pupil diameter was measured with a Colvard pupillometer (Oasis Medical, Inc.). Quantitative analysis of halos was performed by measuring the area using a new computerized method. Pupil size and halo size were evaluated under scotopic and normal room light conditions. Alphagan was administered, and the effect was measured after 30 minutes and 1, 6, 12, and 24 hours.
There was a statistically significant correlation between pupil size and halo size (r = 0.527; P<.0001; slope = 691.6 pixel/mm). Pupil size and halo size decreased significantly 30 minutes after Alphagan instillation under both luminance conditions (all P< .0001). Under normal room light, the pupil and halo remained decreased until the last measurement at 24 hours. Under scotopic conditions, the pupil returned to its preinstillation size at 24 hours while the halo remained decreased. The maximum effect on halos was observed after 6 hours, when the mean reduction over preinstillation size was 28.2% and 29.1% under normal room light conditions and scotopic conditions, respectively.
Alphagan effectively reduced halo size and pupil size in postoperative LASIK patients with night-vision symptoms.
To determine the efficacy of brimonidine tartrate 0.2% drops given 2 times a day in reducing intraocular pressure (IOP) spikes during the first 24 hours after phacoemulsification cataract surgery.
Department of Ophthalmology, General Hospital of Patras Agios Andreas, Patras, Greece.
In this prospective double-blind placebo-controlled study, 1 eye of 40 consecutive normotensive cataract patients having small-incision cataract surgery was randomized into 1 of 2 treatment arms. Twenty patients received a placebo (artificial tears) and 20 patients received brimonidine tartrate 0.2% drops 2 times a day the day before and the day of surgery. Diurnal IOP variation was the primary efficacy variable; IOP was measured at baseline, before surgery, and 4, 6, 12, and 24 hours postoperatively.
The placebo group had higher IOPs at every time point after surgery. Peak elevation of IOP occurred 6 hours after surgery. The mean IOP in the placebo group (27.71 mm Hg +/- 3.75 [SD]) was statistically significantly higher than in the brimonidine group (21.45 +/- 1.32 mm Hg) (P<.001). A major IOP rise (>/=20 mm Hg above baseline IOP) occurred in 1 patient (5%) in the placebo group who required emergency hypotensive therapy. Twenty-four hours after surgery, 11 eyes (55%) in the brimonidine group and 4 eyes (20%) in the placebo group had an IOP lower than baseline.
Prophylactic treatment with brimonidine tartrate 0.2% 2 times a day for 2 days was effective in reducing IOP peaks throughout the first 24 hours after phacoemulsification surgery.
To evaluate the effect of brimonidine tartrate 0.2% ophthalmic solution on pupil size under scotopic and photopic luminance conditions in persons considering laser refractive surgery.
Ophthalmic Health Center, Tel Aviv, Israel.
The pupil size was measured in 36 eyes of 36 participants under scotopic and photopic conditions using the Colvard pupillometer (Oasis Medical) before and after brimonidine tartrate drops were administered. The pupil size was subsequently measured after 30 minutes and 4 and 6 hours.
No difference was found in pupil size before brimonidine tartrate instillation in eyes with light or dark irides. Before instillation, the mean photopic pupil size was 4.81 mm +/- 0.54 (SD) (range 4.0 to 6.0 mm). At 30 minutes, all pupils became miotic, with a mean size of 3.77 +/- 0.51 mm (range 3.0 to 5.0 mm) (P<.0001). After 6 hours, 27.8% of the pupils had returned to their previous size. Before brimonidine tartrate administration, the mean scotopic pupil size was 6.22 +/- 0.73 mm (range 5.0 to 8.0 mm). There was significant miosis to 4.57 +/- 0.84 mm (range 3.0 to 6.5 mm) (P<.0001) that continued for at least 6 hours. The miotic effect of brimonidine tartrate was stronger in eyes with light irides.
Brimonidine tartrate caused significant miosis, especially under scotopic conditions, most likely from its alpha-2 adrenergic effect. Under photopic luminance conditions, the miotic effect was pronounced.
To evaluate the effect of brimonidine tartrate ophthalmic solution 0.2% (Alphagan) on pupil size in normal eyes. Three luminance conditions were used to assess the potential use of brimonidine in postoperative refractive patients who experience nighttime vision problems related to large pupil size.
McDonald Eye Associates, Fayetteville, Arkansas, USA.
Pupil size was measured in 16 eyes of 16 participants with the Colvard pupillometer under 3 luminance conditions. One drop of brimonidine 0.2% was administered to each patient. Pupil size was then measured using the same technique 30 minutes and 4 and 6 hours after drop administration.
Under scotopic conditions, 100% of the pupils showed significant miosis at 30 minutes (P <.05). The effect continued in all eyes for 4 hours. At 6 hours, a miotic effect was still present in 81.3%. However, under photopic luminance, there was no significant effect on pupil size in all 16 eyes (P >.05). The pupil size in 5 eyes (31.2%) was not affected at 30 minutes or 4 or 6 hours. At 6 hours, 15 eyes (93.8%) had returned to their preinstillation size.
Brimonidine tartrate 0.2% had a significant effect in decreasing pupil size under scotopic conditions. The results indicate that the drug can decrease night-vision difficulties such as halos, star bursts, glare, and monocular diplopia in postoperative refractive patients.
To assess the effect of a combination of proparacaine 0.50%-sodium fluorescein 0.25% and ultrasound (US) pachymetry on central and midperipheral corneal thickness.
School of Optometry and Vision Sciences, Cardiff University, Cardiff, Wales, United Kingdom.
Topographic measurements of corneal thickness in healthy right eyes were obtained using a scanning-slit device (Orbscan IIz) and a Scheimpflug device (Pentacam) before and after application of proparacaine 0.50%-sodium fluorescein 0.25% and US pachymetry. Changes in corneal thickness in the center and 2.5 mm from the center in the temporal, nasal, inferior, and superior locations were assessed.
The study evaluated 35 eyes. The scanning-slit and Scheimpflug devices recorded a small but statistically significant increase in corneal thickness at all locations (mean 4.9 ± 14.3 [SD] to 9.1 ± 11.7 μm; P<.05, paired t test). The cornea swelled uniformly across its diameter (scanning slit, P=.934; Scheimpflug, P=.654; analysis of variance); there was no statistically significant difference in the amount of swelling between the 2 devices (P>.05, t test). The 95% limits of agreement were broad (-10 to +30 μm), suggesting a large degree of interindividual variability.
Ultrasound pachymetry combined with proparacaine 0.50%-sodium fluorescein 0.25% caused a small (<10 μm) but significant amount of corneal swelling on average. Because the effect on corneal thickness may be greater than -10 to +30 μm in individual cases, clinicians should avoid contact procedures before obtaining topographic maps of corneal thickness using scanning-slit and Scheimpflug devices.
To investigate the penetration of topically applied levofloxacin 0.5% and ofloxacin 0.3% eyedrops into the aqueous humor of patients having cataract surgery.
Hochkreuzklinik Eye Hospital, Bonn, Germany.
In this randomized, investigator-masked study, 69 patients received 4 drops of either levofloxacin 0.5% or ofloxacin 0.3% eyedrops within 1 hour (60 min, 45 min, 30 min, and 15 min) of elective cataract surgery. Aqueous humor samples of at least 50 muL were drawn from the anterior chamber at the beginning of the cataract operation. The concentrations of the fluoroquinolones in the anterior chambers were measured using high-performance liquid chromatography. To exclude a dilution effect of the anterior chamber (AC), they were related to the AC volumes (measured by 3-dimensional modeling of central Orbscan [Bausch & Lomb] slit-image photos) and AC depths (measured by ultrasound).
The mean concentration of levofloxacin (1139.9 ng/mL +/- 717.1 [SD]) in the aqueous humor was significantly higher (P = .0008) than that of ofloxacin (621.7 +/- 368.7 ng/mL). The aqueous humor concentrations correlated negatively with the measured volumes and depths of the ACs.
The new fluoroquinolone, levofloxacin, is more soluble in water enabling the use of higher drug concentrations (0.5%) compared with other currently available fluoroquinolone eyedrops (0.3%). The concentration AC with levofloxacin eyedrops was about 2-fold that reached with ofloxacin eyedrops. The concentration of the antibacterial isomer was approximately 3.5 to 4 times higher when levofloxacin was administered, assuming negligible stereoselective uptake.
To determine whether gatifloxacin 0.3% ophthalmic solution or moxifloxacin 0.5% ophthalmic solutions are toxic to the corneal epithelium when used with 1 of 2 dosing regimens in healthy human eyes.
Price Vision Group, Indianapolis, Indiana, USA.
In this double-masked randomized fellow-eye comparison study, gatifloxacin 0.3% was instilled in 1 eye and moxifloxacin 0.5% in the other eye either 4 times a day for 7 days or hourly for 10 hours. Before and after dosing, all eyes were examined with a slitlamp and the cell layers in the central cornea were evaluated by confocal microscopy. Subject discomfort with study drop instillation was also assessed.
There was no statistically significant increase in the incidence or severity of superficial punctuate keratitis following use of gatifloxacin 0.3% or moxifloxacin 0.5% when instilled 4 times a day for 7 days or hourly for 10 hours. Hourly use of gatifloxacin 0.3% for 10 hours resulted in a mild but statistically significant increase in conjunctival hyperemia (P = .029). Use of moxifloxacin 0.5% resulted in a small but statistically significant deterioration of the corneal epithelial surface as assessed by confocal microscopy (P = .045). The incidence of subject discomfort with study drop instillation was comparable for the 2 antibiotics (P = .67).
Use of ophthalmic solutions of gatifloxacin 0.3% or moxifloxacin 0.5% did not result in clinically significant epithelial toxicity in healthy human corneas after dosing regimens of 4 times a day for 7 days or hourly for 10 hours dosing regimens.
To evaluate once-daily nepafenac 0.3% to prevent and treat ocular pain and inflammation after cataract surgery.
Sixty-five centers in the United States and Europe.
Randomized double-masked vehicle- and active-controlled phase 3 study.
Patients received nepafenac 0.3% once daily, nepafenac 0.1% 3 times daily, or their respective vehicles from day -1 to day 14 after cataract extraction. An additional drop of study drug was administered 30 to 120 minutes preoperatively. The primary endpoint was the percentage of patients with a cure for inflammation (score of 0 for both aqueous cells and flare) at day 14.
Of randomized patients, 817 received nepafenac 0.3%, 819 received nepafenac 0.1%, and 200 and 206 received the respective vehicles. Significantly more nepafenac 0.3% patients had no inflammation (68.4% versus 34.0%) and were pain free (91.0% versus 49.7%) at day 14 than vehicle patients (both P<.0001). Nepafenac 0.3% was noninferior to nepafenac 0.1% for inflammation (95% confidence interval [CI], -5.73% to 3.17%) and pain-free rates (95% CI, -3.08% to 2.70%). At all postoperative visits, fewer treatment failures (P≤.0012) and more clinical successes (P≤.0264) were observed with nepafenac 0.3% versus vehicle. Nepafenac 0.3% was well tolerated and had a safety profile comparable to that of nepafenac 0.1%.
Once-daily nepafenac 0.3% was noninferior to nepafenac 0.1% 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery. The safety of nepafenac 0.3% was comparable to that of nepafenac 0.1%, with the added convenience of once-daily dosing.
Drs. Modi, Lehmann, Walters, Fong, Christie, Roel, Nethery, and Reiser have been paid consultants to Alcon Research, Ltd. Ms. Sager is an employee of Alcon Research, Ltd. Drs. Tsorbatzoglou, Philipson, and Traverso have no financial or proprietary interest in any material or method mentioned.
To compare the efficacy of povidone-iodine 1.0%, 5.0%, and 10.0% in combination with topical levofloxacin 0.3% in reducing the preoperative conjunctival bacterial load before cataract surgery.
Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.
Randomized clinical trial.
This study enrolled patients scheduled for cataract surgery between July 2010 and January 2011. All patients received topical levofloxacin 0.3% 4 times on the preoperative day and were randomly assigned to these study groups: Group 1 (povidone-iodine 1.0%), Group 2 (povidone-iodine 5.0%), and Group 3 (povidone-iodine 10.0%). In all groups, the conjunctiva was flush irrigated with 10 mL of povidone-iodine of the respective concentration. Conjunctival specimens were obtained at 4 timepoints: baseline (no-surgery eye), before povidone-iodine irrigation, after povidone-iodine irrigation, and at the end of surgery. All specimens were inoculated onto blood and chocolate agars and into thioglycolate broth.
The study was completed by 271 patients. In the control smear (no-surgery eye), no significant difference in positive cultures was found. After 10 mL povidone-iodine irrigation, a considerable reduction in the conjunctival bacterial load occurred in all groups. The difference in positive cultures was statistically significant between Group 1 and Group 3 (P=.024) and between Group 2 and Group 3 (P=.029). Coagulase-negative Staphylococcus was the most commonly isolated bacteria in all groups.
Povidone-iodine 10.0% was more effective than povidone-iodine 1.0% and 5.0% in decreasing the conjunctival bacterial load before surgery.
No author has a financial or proprietary interest in any material or method mentioned.
To evaluate quantitatively over time the reduction in bacterial flora on the human conjunctiva after treatment with topical ciprofloxacin 0.3% (Ciloxan) or topical ofloxacin 0.3% (Ocuflox).
Sinai Hospital of Baltimore, Baltimore, Maryland, USA.
Three study arms each consisted of 20 culture-positive eyes from patients 55 years or older. Pretreatment cultures were performed in all eyes. Eyes in the ciprofloxacin and ofloxacin arms received 1 antibiotic drop every 5 minutes for 3 doses. The conjunctiva of each treatment eye was recultured 15, 30, 60, and 120 minutes after application of the final antibiotic drop. Eyes in the control arm were recultured at corresponding time points. After 48 hours of incubation, colony counts were performed. Data were transformed into log units, and statistical analysis was performed. When compared to no treatment, instillation of ofloxacin 0.3% did not produce a significant reduction in bacterial colony forming units (CFUs) at 15, 30, or 60 minutes (P =.17). A marginally significant reduction was achieved 120 minutes after administration (P =.051).
When compared to no treatment, instillation of ciprofloxacin 0.3% produced a significant reduction in bacterial CFUs at 15 minutes; this effect persisted for at least 2 hours (P <.0001). The reduction in bacterial CFUs by ciprofloxacin was significantly greater than that by ofloxacin at all measurements (P <.0001).
Ciprofloxacin 0.3% markedly reduced bacterial flora on the ocular surface within 15 minutes of instillation, and the effect lasted for at least 2 hours.
To evaluate the safety and analgesic efficacy of ketorolac tromethamine 0.4% ophthalmic solution in postoperative photorefractive keratectomy (PRK) patients.
Fifteen clinical sites in the eastern and southern United States.
This pooled analysis of 2 multicenter, randomized, double-masked, vehicle-controlled, parallel-group studies comprised 313 patients having unilateral PRK. After surgery, patients were treated with 1 drop of ketorolac tromethamine 0.4% ophthalmic solution (Acular(R) LS) (n = 156) or vehicle (n = 157) 4 times daily for up to 4 days. Pain intensity, pain relief, use of escape medication, and severity of ocular symptoms were assessed. Adverse events, epithelial healing, and visual acuity were recorded.
There was significantly less pain intensity experienced by patients in the ketorolac group (P<.001). During the first 12 hours post PRK, 50% fewer patients in the ketorolac group than in the vehicle group had severe to intolerable pain (41.6% [64/154] and 84.5% [131/155], respectively). The median time to no pain was 30 hours in the ketorolac group and 54 hours in the vehicle group (P<.001, survival analysis). Ketorolac patients reported significantly greater pain relief than vehicle patients throughout the study (P<.001). Ketorolac patients used significantly less escape medication than vehicle patients for 48 hours post PRK (P< or =.008). Treatment-related adverse events occurred in 2.6% (4/156) of ketorolac patients and 6.4% (10/157) of vehicle patients.
Ketorolac 0.4% ophthalmic solution is safe and effective in reducing ocular pain when used 4 times daily for up to 4 days post PRK.
To assess the clinical benefit, relative efficacy, and pharmacokinetic-response curve of preoperative and postoperative ketorolac tromethamine 0.4% (Acular LS) to improve outcomes during and after cataract surgery.
Private clinical practice.
One hundred patients were randomized in a double-masked fashion to 4 groups of 25 to receive ketorolac for 3 days, 1 day, or 1 hour or a placebo before phacoemulsification. All treatment groups received ketorolac 0.4% for 3 weeks postoperatively; the placebo group received vehicle. Outcomes measures were preservation of preoperative mydriasis, phacoemulsification time and energy, operative time, corneal clarity, endothelial cell counts, postoperative inflammation, intraoperative and postoperative discomfort, complications, and incidence of clinically significant cystoid macular edema (CME).
Maintenance of pupil size with 3-day ketorolac dosing was significantly better than with 1-day dosing (P<.01), which was significantly better than with 1-hour or placebo dosing (P<.01). Both 3-day and 1-day dosing were superior to 1-hour or placebo dosing. No patient receiving ketorolac 0.4% for 1 or 3 days developed CME compared with 12% of patients in the control (placebo) group and 4% in the 1-hour group. Three-day and 1-day dosing of ketorolac reduced surgical time, phacoemulsification time and energy, and endothelial cell loss and improved visual acuity in the immediate postoperative period compared with 1-hour predosing and the placebo (P<.05).
The preoperative use of ketorolac tromethamine 0.4% for 3 days followed by 1-day of predosing provided optimum efficacy and superior outcomes relative to 1-hour pretreatment and a placebo.
To assess the efficacy of lidocaine gel, bupivacaine drops, and benoxinate drops as topical anesthetic agents in cataract surgery.
Kasr El-Aini Hospital, Cairo University, Cairo, Egypt.
This prospective randomized study comprised 90 patients scheduled for routine cataract extraction. Patients were randomized into 3 groups of 30 each based on which anesthetic agent they received: lidocaine 2% gel, bupivacaine 0.5% drops, or benoxinate 0.4% drops. Subjective pain at application of the agent and intraoperatively was quantified by the patients using a verbal pain score (VPS) scale from 0 to 10. The duration of discomfort at application, duration of surgery, rate of supplemental sub-Tenon's anesthesia, and complications were recorded.
The mean VPS at application was 2.97, 1.53, and 1.03 in the lidocaine, bupivacaine, and benoxinate groups, respectively; the VPS in the lidocaine group was statistically significantly higher than in the other 2 groups (P<.001). The mean duration of pain at application was 25 seconds, 14 seconds, and 6 seconds in the lidocaine, bupivacaine, and benoxinate groups, respectively, and was statistically significantly higher in the lidocaine group (P<.001). The mean VPS during surgery was 1.6, 4.1, and 7.1 in the lidocaine, bupivacaine, and benoxinate groups; the lidocaine group had a statistically significantly lower mean VPS than the other 2 groups (P<.001). The incidence of supplemental sub-Tenon's injection was 3.3%, 10.0%, and 73.3%, respectively, and was statistically significantly lower in the lidocaine and bupivacaine groups than in the benoxinate group (P<.001). The patients' overall satisfaction was statistically significantly higher in the lidocaine and bupivacaine groups than in the benoxinate group (93.3%, 83.3%, and 33.3%, respectively) (P<.001). Three patients in the lidocaine group had corneal haze at the time of surgery, which was not statistically significant (P>.1).
Lidocaine gel was a better topical anesthetic agent than bupivacaine and benoxinate drops. Bupivacaine drops were effective in providing deep topical anesthesia.
To compare the efficacy of a topical nonsteroidal antiinflammatory agent (ketorolac tromethamine ophthalmic solution 0.5%) and a topical steroid (loteprednol etabonate ophthalmic suspension 0.5%) in controlling inflammation after cataract surgery.
Magill Research Center for Vision Correction, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA.
Sixty patients were prospectively and randomly assigned to receive topical treatment with ketorolac tromethamine ophthalmic solution 0.5% or loteprednol etabonate ophthalmic suspension 0.5% starting the day after routine phacoemulsification for cataract extraction. Both patient and investigator were masked to treatment. All patients had uneventful small-incision phacoemulsification with placement of a foldable posterior chamber intraocular lens (IOL). Patients used 1 of the 2 antiinflammatory agents 4 times a day starting 24 hours after surgery. Signs and symptoms of inflammation as documented by external slitlamp examination, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated on postoperative days 1, 4, 7, and 30.
There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements or in IOP between groups. No patient in either group was removed from the study for lack of treatment efficiency.
Ketorolac tromethamine ophthalmic solution 0.5% was as effective as loteprednol etabonate ophthalmic suspension 0.5% in reducing inflammation after routine phacoemulsification and IOL implantation. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.
To compare the efficacy of brinzolamide 1% with that of apraclonidine 0.5% in preventing intraocular pressure (IOP) rise after neodymium:YAG (Nd:YAG) laser posterior capsulotomy.
Department of Ophthalmology, Akdeniz University, Antalya, Turkey.
One hundred fifteen patients who had Nd:YAG laser posterior capsulotomy for posterior capsule opacification were prospectively randomized to receive brinzolamide 1% (57 patients) or apraclonidine 0.5% (58 patients) approximately 1 hour before laser surgery. A masked observer measured IOP by Goldmann applanation tonometry before treatment and after treatment at 1, 2, and 3 hours and 7 days.
The mean IOP changes from baseline were not statistically different between the study groups at 1, 2, and 3 hours and 7 days (P =.109, P = .764, P =.275, and P =.879, respectively). The incidence of IOP elevation of 5 mm Hg or higher was 12.2% (7 of 57 eyes) in the brinzolamide group and 10.3% (6 of 58 eyes) in the apraclonidine group (P = .743); IOP elevations of 10 mm Hg and greater occurred in 3.5% (2 of 57 eyes) and 1.7% (1 of 58 eyes) (P = .618), respectively. There were no IOP elevations greater than 20 mm Hg in either group.
Brinzolamide 1% and apraclonidine 0.5% given prophylactically before Nd:YAG laser capsulotomy were effective in preventing IOP spikes after treatment.
To determine the safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution (Vigamox) in patients having cataract surgery.
American Eye Center, Manila, Philippines.
Preoperative and 1-month postoperative anterior chamber reaction, corneal endothelial cell density, and corneal thickness were assessed in 65 eyes that had cataract surgery with intracameral moxifloxacin. All eyes received 0.1 mL intracameral moxifloxacin 0.5% ophthalmic solution containing 500 mug of moxifloxacin as the last step of phacoemulsification. Different ophthalmologists conducted the postoperative evaluation in an observer-masked fashion. A P value less than 0.05 was considered significant.
All 65 eyes completed the study. The mean age was 69.5 years +/- 9.13 (SD) (range 48 to 84 years). All eyes had a postoperative best corrected visual acuity of 20/30 or better. All eyes had trace to +2 cells and flare anterior chamber reaction only on the first day after surgery. The mean endothelial cell count was 2491.52 cells/mm(2) preoperatively and 2421.58 cells/mm(2) postoperatively. The mean difference was 70 cells/mm(2), which not statistically significant (P = .737). The increase of 17.80 microm in postoperative pachymetry 1 month after surgery was not statistically significant (P>.65).
Intracameral Vigamox 0.5 mg/mL appeared to be nontoxic in terms of visual rehabilitation, anterior chamber reaction, pachymetry, and corneal endothelial cell density.
To determine the penetration of moxifloxacin 0.5% in the human aqueous and vitreous when delivered by a presoaked collagen shield.
University-based clinical practice.
Moxifloxacin 0.5% was administered before vitrectomy surgery in 10 patients using a 24-hour dissolvable cross-linked corneal collagen shield delivery device. Aqueous and vitreous samples were obtained after the shield was placed for 4 hours in the first 5 patients and for 24 hours in the second 5 patients. Assays were performed using high-performance liquid chromatography.
Delivery of moxifloxacin via a collagen shield revealed a mean aqueous concentration of 0.30 microg/mL +/- 0.17 (SD) 4 hours after placement (n = 5). Vitreous levels at 4 hours and aqueous and vitreous levels at 24 hours were negligible using this route of administration. Peak aqueous moxifloxacin levels occurred soon after shield placement. This is when high concentrations of moxifloxacin are most needed to clear the aqueous of bacteria. The minimum inhibitory concentration at which 90% of the isolates were inhibited for organisms commonly responsible for endophthalmitis was exceeded in the 4-hour aqueous group. Negligible concentrations were detected at 24 hours.
Although aqueous moxifloxacin levels achieved through the use of a collagen shield delivery device are lower than via topical drops, there are several advantages to this route of delivery that make it appealing in the immediate postoperative period. Future studies will be needed to define precisely the role of fourth-generation fluoroquinolones and presoaked collagen shields in the prophylaxis or management of intraocular infections.
To compare the efficacy of a topical nonsteroidal anti-inflammatory agent (ketorolac tromethamine 0.5%) with that of a topical steroid (rimexolone 1%) to control inflammation after cataract surgery.
Storm Eye Institute, Department of Ophthalmology, Medical University of South Carolina, Charleston, South Carolina, USA.
Thirty-six patients were prospectively and randomly assigned to receive topical treatment with either ketorolac tromethamine 0.5% or rimexolone 1% starting the day after routine cataract extraction. Treatment was masked to both patient and investigator. Each patient had uneventful small incision phacoemulsification with placement of a foldable posterior chamber intraocular lens. Patients used 1 of the 2 antiinflammatory agents 4 times each day starting 24 hours after surgery. No antiinflammatory medications were used preoperatively, intraoperatively, or for 24 hours postoperatively. Signs and symptoms of inflammation, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated 1, 4, 7, and 30 days postoperatively.
There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements. In addition, there was no difference in IOP measurements between groups.
Ketorolac tromethamine 0.5% was as effective as rimexolone 1% in reducing inflammation after cataract surgery. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.
To determine the aqueous humor concentrations of moxifloxacin and besifloxacin after routine preoperative topical dosing in patients having cataract surgery.
Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA.
In this prospective randomized parallel double-masked clinical trial, 1 drop of commercially available moxifloxacin 0.5% ophthalmic solution or besifloxacin 0.6% ophthalmic suspension was administered every 10 minutes for a total of 4 doses beginning 1 hour before routine cataract surgery. Aqueous humor was sampled via the paracentesis, and antibiotic concentrations were determined using validated high-performance liquid chromatography procedures.
The study enrolled 50 patients. The aqueous concentration of the antibiotic agent was detectable in all 23 moxifloxacin samples and in 10 (40%) of the 25 besifloxacin samples (P<.0001, Pearson chi-square test). The mean aqueous concentration in the moxifloxacin samples was 50-fold higher than in the besifloxacin samples (1.6108 microg/mL versus 0.0319 microg/mL) when all samples were included (P<.0001, Wilcoxon test), while the moxifloxacin concentration was 38-fold higher than the besifloxacin concentration (1.6108 microg/mL versus 0.0422 microg/mL) in the samples with detectable antibiotic agent (P<.0001).
After topical preoperative administration, moxifloxacin 0.5% ophthalmic solution had a 38-fold to 50-fold higher concentration in the aqueous humor than besifloxacin 0.6% ophthalmic suspension. Besifloxacin was undetectable in more than half the aqueous humor samples.
To assess the anesthetic efficacy of tetracaine hydrochloride 0.5% (TetraVisc) versus lidocaine 2% jelly in routine cataract extraction.
Private surgicenter, Warwick, Rhode Island, USA.
A prospective randomized double-blind clinical trial comprised 100 patients having routine cataract extraction by clear corneal phacoemulsification. Patients were randomized to receive TetraVisc or lidocaine 2% jelly, applied once, approximately 5 minutes before surgery. Outcomes included a self-reported postoperative pain score and the need for supplemental anesthesia.
The mean self-reported postoperative pain scores for TetraVisc and lidocaine 2% jelly were similar (0.94 and 1.02, respectively; P = .76). A single patient in the lidocaine group required supplemental anesthesia.
TetraVisc was as effective as lidocaine 2% jelly as a topical anesthetic agent for routine cataract extraction.
To compare the anti-inflammatory and analgesic efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution with those of prednisolone acetate 1% in patients having cataract surgery.
Shawnee Mission Eye Care, Shawnee Mission, Kansas, USA.
This double-blind, randomized, single-site study comprised 59 healthy men and women with a clinical diagnosis of routine ocular cataract requiring surgical removal. All patients had extracapsular cataract extraction and posterior chamber intraocular lens implantation. After surgery, patients were randomized to receive ketorolac tromethamine 0.5% or prednisolone acetate 1%, self-instilled in the treated eye, according to the following schedule: 1 to 2 drops 4 times daily (week 1); 3 times daily (week 2); 2 times daily (week 3); once daily (week 4). Patients were examined postoperatively on days 1, 7, and 28. Intraocular anti-inflammatory efficacy was assessed by lid edema, lid injection, conjunctival injection, corneal edema, ciliary flush, and anterior chamber cells. Analgesic efficacy was assessed by patient self-rated pain severity, pain frequency, total symptom sum, and overall global improvement.
Both treatments produced comparable reductions in intraocular inflammation and pain after cataract surgery and were well tolerated by patients. No adverse events were reported, and there were no significant changes in intraocular pressure in either group. Improvements in visual acuity were also similar in both groups.
Ketorolac tromethamine 0.5% ophthalmic solution was as effective and well-tolerated as prednisolone acetate 1% solution in controlling postoperative inflammation and pain after cataract surgery.
To evaluate the safety of trypan blue 1% and indocyanine green (ICG) 0.5% in assisting visualization of anterior capsule during phacoemulsification in mature cataract.
Department of Ophthalmology, United Christian Hospital, Hong Kong, China.
This prospective randomized clinical trial comprised 46 eyes with mature cataract receiving phacoemulsification and posterior chamber intraocular lens implantation. They were randomized into 3 groups (trypan blue, ICG, and control without stain). Visual acuity, endothelial cell count, corneal clarity, anterior chamber reaction, and intraocular pressure (IOP) were documented before surgery and 1 week, 1 month, and 3 months postoperatively. The absolute phaco time was also recorded.
There was no significant difference in absolute phaco time (P=.17), mean endothelial cell loss (P=.72 at 1 week, P=.43 at 1 month, and P=.60 at 3 months) and no significant correlation between the absolute phaco time and the change in endothelial cell count (P=.50 at 1 week, P=.10 at 1 month, and P=.60 at 3 months) in the 3 groups. None of the patients had postoperative IOP greater than 21 mm Hg. All eyes had clear corneas and a quiet anterior chamber 3 months after surgery.
Both trypan blue 1% and ICG 0.5% are safe for assisting visualization of the anterior capsule during phacoemulsification of mature cataract.
To evaluate the efficacy of loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the control of postoperative inflammation in patients having routine cataract surgery.
Private practice, Stillwater, Minnesota, and Cincinnati Eye Institute, Cincinnati, Ohio, USA.
Comparative case series.
Patients were at least 18 years of age and scheduled for routine cataract surgery. Patients were excluded from the study if they had preexisting medical conditions (ie, elevated intraocular pressure [IOP], retinopathy, maculopathy, uveitis) or required medications the investigator believed would put the patient at risk or confound the study. Patients were randomized to receive loteprednol etabonate or prednisolone acetate 4 times daily in addition to bromfenac 0.09% and besifloxacin 0.6% after surgery. Visual acuity, IOP, and anterior chamber cell and flare intensity were assessed over 3 weeks after cataract surgery. The primary endpoint was the level of anterior chamber cell and flare intensity in patients treated with loteprednol etabonate or prednisolone acetate.
The study enrolled 88 patients (46 loteprednol etabonate, 42 prednisolone acetate). Equivalency was achieved between the 2 treatment groups with no significant differences throughout the 3-week follow-up. There was less fluctuation in IOP assessments in patients treated with loteprednol etabonate than in patients treated with prednisolone acetate, in particular 1 day and 3 days postoperatively.
The results indicate that equivalent control of inflammation can be obtained through treatment with loteprednol etabonate or prednisolone acetate after cataract surgery. In addition, treatment with loteprednol etabonate may result in less IOP fluctuation.
Dr. Lane is a consultant to Bausch & Lomb, Rochester, New York, Alcon Laboratories, Inc., Fort Worth, Texas, and ISTA Pharmaceuticals, Irvine, California, USA. Dr. Holland is a consultant to Bausch & Lomb, Rochester, New York, and Alcon Laboratories, Inc., Fort Worth, Texas, USA. Neither author has a financial or proprietary interest in any material or method mentioned.
To compare selection for fluoroquinolone-resistant bacteria between 1-day and 3-day application of topical moxifloxacin 0.5%.
Department of Ophthalmology, Stanford University, Stanford, California, USA.
After investigative review board approval, patients scheduled for ocular surgery were randomized to receive topical moxifloxacin 0.5% drops 4 times a day for 1 day or 3 days preoperatively. Conjunctival cultures were obtained at baseline and after antibiotic application. Bacteria were identified and tested for resistance to a battery of antibiotic agents using the Kirby-Bauer disk-diffusion method. The differences in resistance distributions for the most commonly isolated bacteria between baseline (T0) and after antibiotic administration (T1) were compared between the 2 treatment groups.
Coagulase-negative Staphylococcus (CNS) were the most common bacteria isolated at T0 and T1. At T0, the proportion of CNS isolated in the 1-day group (n = 63) that was resistant to fluoroquinolones ranged from 4% to 22% depending on the antibiotic agent tested. After 1-day treatment with moxifloxacin, the percentage of resistant bacteria increased significantly (range 13% to 67%) for all fluoroquinolones except gatifloxacin (P<.05). Resistance to gentamicin and tobramycin also increased significantly. However, patients treated for 3 days (n = 57) showed no differences in bacterial resistance rates to any antibiotic agent tested.
Prophylactic topical moxifloxacin 0.5% treatment starting 1 day before ocular surgery resulted in a significant increase in fluoroquinolone-resistant bacteria, while a 3-day antibiotic regimen did not select for resistant organisms.
To compare the efficacy of 30 minute preoperative versus 1 day postoperative administration of ketorolac tromethamine 0.5% ophthalmic solution (Acular) in reducing anterior chamber inflammation after cataract surgery.
The Hermann Eye Center, The University of Texas Health Science Center-Houston, Texas, USA.
Fifty eyes of 48 consecutive patients scheduled for phacoemulsification with intraocular lens implantation were included. Before surgery, patients were randomly assigned to start the study drug 30 minutes preoperatively or 1 day postoperatively. No other antiinflammatory agents were used intraoperatively or postoperatively. Main outcome measures were flare and cell counts.
Preoperative and postoperative flare and cell counts did not differ significantly between the 2 treatment groups at any time. Both groups showed significant increases in flare (P =.0001) and cells (P =.0001) 1 day postoperatively. Flare and cells returned to baseline levels by day 28 in both groups. There was no significant difference at any time between the 2 groups in the change from the preoperative level of inflammation.
There was no difference between administering ketorolac 30 minutes preoperatively versus 1 day postoperatively in reducing inflammation.
To examine the efficacy and safety of a new gel formulation loteprednol etabonate 0.5% in the treatment of inflammation and pain after cataract surgery.
Seventeen United States clinical sites.
Prospective double-masked parallel-group study.
Patients with anterior chamber cell (ACC) grade 2 or higher after cataract surgery were randomized to loteprednol etabonate 0.5% gel or vehicle 4 times a day for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative day 8. Safety measures included adverse events, intraocular pressure (IOP), visual acuity, biomicroscopy and funduscopy findings, and tolerability (ocular symptoms and drop comfort).
The intent-to-treat population included 406 patients (203 per treatment). On day 8, 30.5% of patients in the loteprednol etabonate group and 16.3% of patients in the vehicle group had complete resolution of ACC, whereas 72.9% and 41.9%, respectively, had grade 0 pain (both P<.001). Significant treatment differences for complete resolution of ACC and grade 0 pain favoring loteprednol etabonate were also found on day 15 and day 18. One patient in each treatment group had a significant increase in IOP (≥ 10 mm Hg). Analyses of pain, photophobia, and tearing favored loteprednol etabonate at different time points beginning on day 3. More than 85% of patients in each treatment group reported no discomfort on drop instillation.
Loteprednol etabonate gel 0.5% was efficacious and safe in treating postoperative inflammation and pain.
Dr. Rajpal is a consultant to Bausch & Lomb, Inc., Allergan, Inc., and Alcon Laboratories, Inc. Dr. Siou-Mermet and Ms. Erb are employees of Bausch & Lomb, Inc. Dr. Roel has no financial or proprietary interest in any material or method mentioned.