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The Effect of Prophylactic Nepafenac 0.1% Eye Drops

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The Effect of Prophylactic Nepafenac 0.1% Eye Drops Ophthalmol Ina 2015;41(3):265-271 265 Original Article The Effect of Prophylactic Nepafenac 0.1% Eye Drops on Macular Changes after Phacoemulsiication in Non- Proliferative Diabetic Retinopathy Patients Using Spectral Domain Optical Coherence Tomography (SD-OCT) Soeiandi Soedarman *, Ari Djatikusumo *, Syska Widyawati *, Arini Setiawati ** * Department of Ophthalmology, Faculty of Medicine, Indonesia University Cipto Mangunkusumo Hospital, Jakarta ** Department of Pharmacology & Therapeutic, Faculty of Medicine, Indonesia University Cipto Manungkusumo Hospital, Jakarta ABSTRACT Background: To evaluate the effect of prophylactic nepafenac eye drops on macular thickness changes after phacoemulsiication surgery in mild to moderate NPDR patients. Method: This study is an open label randomized clinical trial. Thirty-six subjects who met the inclusion criteria underwent phacoemulsiication. One group (18 subjects) were given nepafenac 0.1% eye drops and the rest were given placebo. Foveal thickness was measured by SD-OCT before surgery and the fourth week after phacoemulsiication. Best corrected visual acuity (BCVA) and degree of inlammation in the anterior chamber were also being assessed. Result: There was a statistically signiicant increase foveal thickness in the placebo group 4 weeks after phacoemulsiication (p=0.022). Clinically, percentage degree of inlammation in anterior chamber in placebo group was higher than nepafenac group (38.9% : 5.6%) but not signiicantly different between 2 groups (p=0.27). Nepafenac group achieved clinically better BCVA than the placebo group 4 weeks after phacoemulsiication, although statistically there was no signiicant difference between 2 groups (p=0.991). Conclusion: Nepafenac 0.1% eye drops could prevent foveal thickening 4 weeks after phacoemulsiication in mild to moderate NPDR patients. Clinically, nepafenac 0.1% eye drops could decrease the risk of inlammation in the anterior chamber, risk of CME, and vision deterioration although did not reach statistically signiicant. Keywords: Nepafenac, macular thickness, phacoemulsiication, retinopathy diabetic. 266 Ophthalmol Ina 2015;41(3):265-271 Diabetic retinopathy is one of the most common phacoemulsiication in diabetic patients is greater microvascular complications in diabetic patients. (50%) than in patients without diabetes (8%). In a study by Sivaprasad et al1 the prevalence of Subjects with a history of diabetic retinopathy diabetic retinopathy in Asia was 35%, 10% of prior to the phacoemulsiication procedure, a which led to a sharp decline in visual acuity due greater risk of CME was found higher compared to diabetic macular edema (DME). with diabetic patients without history of diabetic A descriptive study by Sya’baniah et al2 in retinopathy before phacoemulsiication (56% vs Indonesia showed that the incidence of diabetic 7%). Kim et al7 discovered that in 22% of patients retinopathy was 24.50%. This number was with diabetic retinopathy who underwent cataract obtained from the screening of all new diabetic surgery had an increase of macular thickness, 1 patients from November 2010 to October 2011. month after phacoemulsiication which caused a Of the 565 patients with diabetic retinopathy, signiicant decline in visual acuity. 200 patients (8.7%) had mild non-proliferative In a meta-analysis, Rosseti et al8 investigate diabetic retinopathy (NPDR) and 207 patients the effectiveness of combined nonsteroidal anti- (11.39%) had moderate non-proliferative inlammatory drugs (NSAID) and corticosteroid diabetic retinopathy (NPDR). eye drops in preventing CME. Another study Aside from diabetic retinopathy, patients by Almeida et al9 in which the prophylactic with diabetes mellitus (DM) also have an use of NSAIDs followed by a combination of increased risk of cataract from 2 to 4 times higher NSAIDs and corticosteroids for 4 weeks after than those without diabetes. It is estimated that phacoemulsiication signiicantly reduce the approximately 20% of cataract patients has had risk for the development of CME compared a history of DM. With the increasing prevalence with postoperative corticosteroid use only. In of DM in Indonesia, the number of diabetic Indonesia, a study by Risriwani et al10 also found patients which needs cataract extraction surgery that the use of prophylactic oral meloxicam is also expected to rise.3-4 followed by combination with corticosteroids One of the most common complications for 2 weeks post phacoemulsiication of diabetes mellitus patients who underwent signiicantly reduce the risk of CME compared cataract surgery is cystoid macular edema with postoperative corticosteroid use only. (CME). Cystoid macular edema is a condition Nepafenac (amfenac amide) is a NSAID, that can cause a decrease in visual acuity. which unlike other ophthalmic NSAIDs, is a The pathogenesis of CME begins with prodrug (an inactive substance that will become trauma of the iris, ciliary body, and lens active after metabolic processes), rather than a epithelial cells after cataract surgery which then free acid. It has the highest corneal permeability cause the release of phospholipids and activate compared to other NSAIDs which will reduce inlammatory mediators such as prostaglandins. the exposure of this drug to the surface of the Prostaglandins as an inlammatory mediators cornea, thereby reducing the risk of corneal derived from every damaged cells in the anterior toxicity. In vitro study using rabbit eyes chamber will diffuse to the posterior thus causing showed nepafenac has roughly 6 times better damage to the blood-retinal barrier (BRB). Blood permeability than diclofenac and performed retinal barrier damage will increase perivofea better in inhibiting the COX-2 activity compared capillary permeability therefore causing luid to ketorolac and bromfenac.11,12 Singh et al13 used accumulation in the outer plexiform layer and a combination of 0.1% nepafenac eye drops and the inner retinal layer.5 1% prednisolone eye drops for 90 days after In patients with DM, BRB damage has phacoemulsiication in patients with diabetic occurred prior to cataract surgery. This will retinopathy with a signiicant reduce in the risk increase the risk of CME development compared of CME compared with 1% prednisolone eye to those without DM. The most common procedure drops monotherapy. of cataract surgery is phacoemulsiication. In This study investigates the changes of a study by Pollack et al6 the risk of CME post- macular thickness in diabetic patients who Ophthalmol Ina 2015;41(3):265-271 267 underwent phacoemulsiication after the Subjects were randomized into two nepafenac 0.1% eye drops administration. groups. In the study group the subjects began to use 0.1% nepafenac eye drops 3 times a day for 3 days before surgery and continued for METHODS 14 days post-surgery. In the control group the subjects used a placebo eye drops with the same This is a prospective, randomized, clinical trial frequency and period of time. with open-blinded evaluation. This research Cataract surgery performed with was conducted at the Eye Clinic of Kirana, Cipto phacoemulsiication method by 2 surgeons. Mangunkusumo Hospital (RSCM) Indo nesia from March to August 2013. The Ethics Committee of Phaco time and the complications of surgery the Faculty of Medicine, University of Indonesia, and type of complications are included in approved this study. the reports. Subjects received postoperative Patients with type 2 diabetes mellitus, cataract treatment in accordance with standard NPDR without CSME according ETDRS criteria, procedures. On the irst day after surgery, NO2, NC2 -NO4, NC4 cataract with or without examination for uncorrected visual acuity using cortical opacities and posterior subcapsular the ETDRS chart, the number of cells and lare (according to the classiication of LOCS III37), using a slit lamp biomicroscopy were performed. indicated for phacoemulsiication surgery, still At 4 weeks after surgery, examination for possible to be assessed for macular thickness best corrected visual acuity with the ETDRS using SD-OCT before surgery is included to the chart, the number of cells and lare using a slit study. All patients are willing to be included in lamp biomicroscopy, foveal thickness with SD- the study and signed an informed consent. OCT were performed. Patients with a history of intraocular All data were analyzed using Microsoft inlammation, glaucoma and abnormality in the Excel 2007 and SPSS (Statistical Package for macular and/or posterior segment, had intra- Social Sciences) for Windows 17.0. Normality test operative and postoperative complications of were performed using Kolmogorov-Smirnov test. phacoemulsiication, had a history of laser photo- The differences in foveal thickness and coagulation, without intraocular lens implan- visual acuity between two groups before and tation during surgery, HbA1c level >11%, and after treatment were analyzed with unpaired uncontrolled hypertension with systolic blood student t-test. The differences in foveal thickness pressure >165 mmHg, and diastolic blood pressure before and after treatment within each group >90 mmHg were excluded from the study. was performed using paired student t-test. The drop-out criteria were inability to The number of cells between the treatment come for follow-up at the appointed time, the and control groups on 1 day and 4 weeks after patient did not comply with the procedures set phacoemulsiication procedure were analyzed out in the study, and patients withdrew during with Kolmogorov-Smirnov test. any time in this
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