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Effect of Topical Ketorolac Tromethamine and Topical

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Effect of Topical Ketorolac Tromethamine and Topical PHILIPPINE JOURNAL OF Vo l . 36 • No. 1 Ophthalmology Ja N u a r y – Ju N e 2011 ORIGINAL ARTICLE Richard Atanis, MD Prospero Ma. Tuaño, MD Effect of topical ketorolac Jay Vicencio, MD Jose Ma. Martinez, MD Lee Verzosa, MD tromethamine and topical International Eye Institute St. Luke’s Medical Center nepafenac on maintaining Quezon City, Philippines pupillary dilation during phacoemulsification ABSTRACT Objective This study compared the effectiveness of prophylactic administration of topical ketorolac tromethamine 0.5% and nepafenac 0.1% on maintaining mydriasis during phacomulsification. Methods This is a prospective, randomized, double-masked comparative study involving adult cataract patients given topical NSAIDs (ketorolac or nepafenac) or balanced salt solution (control) prior to phacoemulsification and capsular bag intraocular-lens (IOL) implantation at a tertiary hospital. Horizontal and vertical diameters of pupil were measured at different stages of cataract surgery and the mean values were compared across the three groups. Results A total of 47 eyes of 44 cataract surgery patients, 13 males and 34 females, with a mean age of 66.04 ± 8.87 years, were included in the study. The mean horizontal and vertical diameters of the three groups were similar at the start of surgery. Significant differences were seen after IOL implantation, with Correspondence to the nepafenac group having the largest mean diameters in both horizontal Richard B. Atanis, MD (p = 0.012) and vertical (p = 0.012) pupil measurements. 2 Champagne St., SSS Village Concepcion Dos, Marikina City Philippines Conclusion Telefax : +63-2-9489342 E-mail : [email protected] Topical nepafenac has been shown to be a more effective inhibitor of miosis during phacoemulsification and provides a more stable mydriatic effect throughout the surgical procedure compared to topical ketorolac and No financial assistance was received for this study. placebo. The authors have no proprietary or financial interest in any product used or cited in this study. Keywords: Cataract, Phacoemulsification, Mydriasis, Topical NSAIDs, Nepafenac, Ketorolac Presented at the annual meeting of the Philippine Academy of Ophthalmology, Manila, Philippines, November 2010. Philipp J oP h t h a l m o l 2011; 36(1):23-27 © PHILIppINE AC A DEMY OF OP HTH A LMOLOGY PHILIppINE AC A DEMY OF OP HTH A LMOLOGY 23 PHACOEMULSIFICATION with intraocular-lens • had normal funduscopic exam (if retina view was (IOL) implantation is the current surgical treatment of possible), choice for cataract extraction.1-3 To prevent complications • had history of unremarkable phacoemulsification during surgery, there should be adequate pupillary dila- with capsular-bag IOL implantation to the contralateral tion for better visualization of the posterior chamber. eye, and Evidence has shown that intraocular manipulation can • had continuous, circular capsulorhexis of 5 to 6 trigger the inflammatory cascade, releasing cyclooxyge- mm diameter. nase (COX) and prostaglandins within the eye causing The exclusion criteria included: miosis. During cataract surgery, maintenance of mydriasis • history of ocular inflammatory or infectious eye is necessary to facilitate proper incision of the anterior disease, capsule, safe removal of the cataract, and implantation of • treatment of eye infection within 30 days prior to intraocular lens. inclusion in the study, Mydriatics and antiprostaglandins are routinely • alterations of the ocular surface (e.g., dry eye), applied preoperatively to facilitate cataract extraction • history of ipsilateral ocular surgery and/or trauma, and prevent intraoperative miosis.4 Previous studies • history of any neuro-ophthalmologic pathologies, have demonstrated the effectiveness of various topical • knowledge or suspicion of allergy or hypersensitiv- nonsteroidal antiinflammatory drugs (NSAIDs) (indo- ity to the preservatives, steroids, topical NSAIDs, or any methacin, flurbriprofen, suprofen) in preventing miosis other component of the study medication, during cataract surgery compared to placebo.5 Newer • use of topical ophthalmic medications, topical NSAIDs also showed similar favorable effects. • use of topical or systemic steroids within 30 days Coste6 showed that nepafenac given 3 times a day 1 prior to inclusion in the study, day before cataract surgery was superior to tobramycin- • use of topical or systemic NSAIDs within 14 days dexamethasone eye drops in maintaining intraoperative prior to inclusion in the study, mydriasis measured at 4 different stages of the surgery. • diagnosis of diabetes mellitus with/without diabetic Solomon5 compared the effects of topical 0.5% ketorolac retinopathy and/or macular edema, tromethamine ophthalmic solution with topical 0.03% • preoperative mydriasis less than 6 mm prior to the flurbiprofen sodium on the inhibition of surgically study, induced miosis during phacoemulsification. Ketorolac • “Phaco time” of >1.5 minutes, provided a more stable mydriatic effect throughout the • intraoperative posterior capsular rent with or with- surgical procedure. out vitreous loss, This study compared the effect of 2 newer topical • use of intraoperative intracameral epinephrine, NSAIDs widely available in the Philippines—ketorolac • ocular alteration preventing adequate mydriasis 0.5% and nepafenac 0.1%. Specifically, this study deter- (eg. synechiae, iris atrophy), mined the horizontal and vertical pupillary diameters • use of contact lens at anytime before the surgery, in 4 different stages of phacoemulsification; compared • surgical events that may hasten pupillary constric- pupillary diameter measurements among the ketorolac, tion (eg. inadvertent manipulation/aspiration of the iris, nepafenac, and placebo groups; and determined the incarceration of iris into the main wound secondary to total loss and percent total loss of mydriasis. an accidentally shortened or mis-angled main corneal tunnel), METHODOLOGY • use of tamsulosin or other analogous systemic medi- We conducted a prospective, randomized, double- cations that may induce increased tendency for miosis masked comparative study involving 47 eyes of 44 Filipino intra-operatively (intra-operative floppy iris syndrome or patients diagnosed with mature cataract who underwent IFIS). cataract surgery by phacoemulsification and capsular bag IOL implantation in a tertiary hospital from March to Preoperatively, all subjects underwent a thorough August 2010. ophthalmic examination. Past medical and surgical his- Included were patients who: tory, and use of concurrent medications were extensively • were 40 years of age or older, reviewed. Best-corrected visual acuity (BCVA) using the • had been diagnosed with mature cataract according ETDRS chart, slit-lamp biomicroscopy, intraocular pres- to the Lens Opacities Classification System (LOCS III), sure by Goldmann applanation tonometry, and dilated- with classification NO and/or NC 2–3, fundus examination were done. • were scheduled for cataract surgery by phacoemul- A general surgical consent form was obtained from all sification and capsular bag IOL implantation, patients. Patients who underwent phacoemulsification 24 Philipp J oP h t h a l m o l Vo l . 36 No. 1 Ja N u a r y – Ju N e 2011 PHILIppINE AC A DEMY OF OP HTH A LMOLOGY were eligible for inclusion. They as follows. Two 1-mm side-ports, a magnification (0,75x) of the operat- were randomly assigned to each of 2.75-mm temporal clear corneal inci- ing microscope was ensured at each the 3 groups based on which of the 3 sion, and a 5- to 6-mm continuous of the 4 time points. sealed envelopes was chosen by a ju- curvilinear capsulorhexis were made. The primary outcome measures nior resident at the time of surgery. Phacoemulsification parameters were the mean horizontal and verti- Patients received 1 drop of the were established prior to all surger- cal diameters of the pupil during the assigned topical NSAID or balanced ies and were the same in all patients. four different stages of phacoemulsi- salt solution (BSS) (control group) Balanced salt solution without epi- fication. every 15 minutes for 4 doses (~20ml) nephrine was used for corneal irriga- Other data collected were age, to the operative site one hour prior tion. The corneal incisions were left gender, laterality of the eye operated to the scheduled operation. Five unsutured at the close of surgery. on, and the corresponding category minutes later, tropicamide 0.5% with To ensure the standardization of to which they were assigned. Fre- phenylephrine 0.5%, 1 drop every 15 illumination during pupillary mea- quency, percentage, mean and stan- minutes for 4 doses was instilled in all surement, all surgeons used the same dard deviation were used to describe treatment groups. The surgeons and microscope (Carl Zeiss OPMI VISU demographic characteristics and the patients were unaware of the type 210 S88) and the illumination was values of pupillary measurements. of test drops given. kept constant (0.5 to 0.7) in all cases. Comparisons of categorical variables All subjects underwent cataract The principal author measured the were analyzed using chi square or surgery by phacoemulsification using horizontal and vertical pupillary Fisher exact tests, where applicable. the Millenium machine (Microsurgi- diameters. A sterile caliper was placed Analysis of variance (ANOVA) was cal System, Houston, TX, USA). over the cornea and measurements used to determine differences A one-piece, monofocal, foldable were taken, in millimeters, under the between groups at each stage
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