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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 33  |  Issue : 4  |  Page : 1131-1138

Nepafenac and bromfenac versus a placebo in minimizing the incidence of pseudophakic cystoid macular edema after phacoemulsification


1 Department of Ophthalmology, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Ophthalmology, Ministry of Health, Dakahlia, Egypt

Date of Submission03-Feb-2020
Date of Decision10-Mar-2020
Date of Acceptance14-Mar-2020
Date of Web Publication24-Dec-2020

Correspondence Address:
Hanan A. E Ahmed Madi
Academic, Degree (MBBCH), Adress Hay El-gamaa Street, Elmansoura city, Dakahlia Governorate
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mmj.mmj_27_20

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  Abstract 

Objectives
This study aims to evaluate the effect of two types of topical NSAIDs, nepafenac and bromfenac, in comparison with a placebo on macular edema after phacoemulsification.
Background
Cystoid macular edema (CME) is the commonest cause of visual decline after phacoemulsification.
Design
A prospective comparative randomized Open-label clinical trial was performed.
Patients and methods
A total of 75 patients with senile cataract were included in the present study. Of them, 19 patients were assigned to receive nepafenac 0.3% eye drops, 19 received bromfenac 0.09% eye drops, and 37 received a placebo. The primary outcome measure included the change in the mean spectral-domain optical coherence tomography central subfield thickness at 1 day, 1 week, 1, 2 and 3 months after surgery. The secondary outcome measures included the total macular volume at 1 day, 1 week, 1, 2, 3 months postoperatively; the percentage of eyes in each group that developed CME; and the corrected visual acuity on 6 and 12 weeks after surgery.
Results
For all retinal thickness measurements, a significant increase in all three groups had been detected, starting from the first week postoperatively. Compared with the control regimen, add-on bromfenac or nepafenac resulted in statistically significant minimization of the changes in the following parameters: change in the macular volume and the central subfield thickness.
Conclusion
Topical NSAIDs therapy 2 days before surgery has an additive effect in minimizing the risk of pseudophakic CME. Bromfenac has statistically surpassed nepafenac in minimizing the incidence of CME after uneventful phacoemulsification.

Keywords: bromfenac, cystoid macular edema, nepafenac, pseudophakic


How to cite this article:
ElSobky HM, Ahmed Madi HA, Aziz MS. Nepafenac and bromfenac versus a placebo in minimizing the incidence of pseudophakic cystoid macular edema after phacoemulsification. Menoufia Med J 2020;33:1131-8

How to cite this URL:
ElSobky HM, Ahmed Madi HA, Aziz MS. Nepafenac and bromfenac versus a placebo in minimizing the incidence of pseudophakic cystoid macular edema after phacoemulsification. Menoufia Med J [serial online] 2020 [cited 2021 Apr 18];33:1131-8. Available from: http://www.mmj.eg.net/text.asp?2020/33/4/1131/304500




  Introduction Top


Cystoid macular edema (CME) following cataract surgery, frequently known as Irvine–Gass syndrome[1], is still recognized as the commonest cause of visual decline after uncomplicated cataract surgery[2]. CME can be attributed to the surgery-induced disruption of the blood–retinal barrier, leading to the accumulation of extracellular intraretinal fluids in the outer plexiform and the inner nuclear retinal layers[3]. The surgical trauma triggers the release of arachidonic acid with the resultant activation of cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) enzymes ending in the production of prostaglandins [Figure 1], the main factor to be accused of edema induction[4],[5],[6],[7]. COX-2 enzyme is considered to be the primary mediator of ocular inflammation[8]. Bromfenac is the most potent topical NSAID regarding its COX-2 inhibitory effect[9],[10]. Nepafenac possesses a unique prodrug structure that facilitates its rapid penetration through the cornea to ultimately reach high levels at the ocular posterior segment, particularly at the macula[11],[12],[13]. After penetrating the cornea, amfenac is converted into nepafenac, which is a potent NSAID[11]. Recent techniques for cataract extraction and the use of a new generation of NSAIDs may have diminished the rate of pseudophakic CME[14]. New generations of optical coherence tomography (OCT) (stratus OCT and OCT3) with the help of adapted analysis software have helped a lot in the detection of subtle changes in macular thickness[15]. It was shown that, even after uneventful cataract surgery, a benign and mild increase in macular thickness without an effect on visual acuity (VA) frequently occurs, even in low-risk patients. Such increase in thickness may last for months[16],[17] and is frequently self-limited with total spontaneous resolution in ~95%, though still, some cases can progress to permanent visual loss[18],[19]. The objective of this study was to assess the validity of evidence supporting the superiority of bromfenac over nepafenac in reducing the chances of developing pseudophakic CME and the superiority of both over placebo.
Figure 1: Action of steroids and NSAIDs on arachidonic cascade. COX, cyclooxygenase; IOP, intraocular pressure; PG, prostaglandin.

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  Patients and Methods Top


Design

A prospective randomized open-label clinical trial study was conducted from August 2018 to August 2019 after approval of the ethical committee of the Faculty of Medicine at Menoufia University. All procedures were carried out under the tents of the Helsinki Declaration. Written consent was provided by all participants after a full explanation of the study. No changes were performed to the protocol after the study initiation.

Patient enrolment

The study included 75 patients.

Inclusion criteria

The study included patients with senile cataract who are 40 years or older and were scheduled for cataract extraction by phacoemulsification with bagal intraocular lens implantation under local anesthesia at the Ophthalmology Department, Faculty of Medicine, Menoufia University.

Exclusion criteria

The study excluded patients with small pupils (<5.0 mm after pharmacological dilatation); patients with dark brown irises; patients with anterior segment pathology such as corneal opacities, pseudo-exfoliation syndrome, or cataract dense enough to interfere with OCT imaging; and patients with a history of uveitis, glaucoma, macular degeneration, or any vision-impairing eye disorder except for cataract. Moreover, patients under current treatment with any form of topical or systemic anti-inflammatory drugs, pregnant women, patients with hypersensitivity to any of the given study medications, patients with eyes with posterior segment pathology such as diabetic retinopathy, patients with previous retinal coagulation therapy, patients with diabetic macular edema, and patients with age-related macular degeneration were excluded. Eyes with intraoperative difficulties such as prolonged surgery time, loose zonular fibers, residual cortical material, or failure of intraocular lens implantation in the capsular bag and those who have experienced intraoperative complications such as posterior capsular rupture or vitreous loss were also excluded.

Study protocol

Preoperative ophthalmologic examination included measurement of uncorrected distance VA and corrected distance visual acuity (CDVA), refraction using auto refractometer (Premio KR10, Medi Science Services, Dhakuria, Kolkata, West Bengal), slit-lamp biomicroscopy (Haag-Streit: Bern, Switzerland), intraocular pressure (IOP) measurement using Goldman applanation tonometer, posterior segment evaluation using Goldman three-mirror lens, and biometry using partial coherence interferometry (IOLMaster Carl Zeiss Meditec AG: Goeschwitzer Strasse 51-52 07745 Jena, Germany). The targeted postoperative refractive error was 0.0 D. The uncorrected distance VA and CDVA were assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) eye meter chart (Landolt 'C' chart) under standardized conditions. The VA measurements were converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis.

The lens was examined using the slit-lamp under a dilation with phenylephrine 2.5% and tropicamide 1.0%. The Lens Opacities Classification System III was used to categorize cataract nuclear opalescence. To control observer bias, the same ophthalmologist examined all patients.

Furthermore, a spectral-domain OCT scan (Heidel-Berg Engineering Inc. 10 Forge Pkwy, Franklin, MA 02038,United States) was performed preoperatively and postoperatively at day 1, 1 week, and then every month for 3 months. All spectral-domain OCT imaging was performed by the same experienced staff, who was blinded to the treatment. Specifically, central subfield thickness (μm) (central 1.0 mm subfield) and total macular volume (mm3) were collected from each patient for statistical analysis.

The patients were randomized in a 1: 1 fashion to one of two treatment groups. The control group received dexamethasone 0.1% and a placebo (artificial tear substitute), and the study group received the test treatments, which was further re-randomized in a 1: 1 fashion into treatment subgroups: the first subgroup received nepafenac ophthalmic suspension 0.1% and dexamethasone 0.1%, and the other subgroup received bromfenac 0.09% and dexamethasone 0.1%. Nepafenac, bromfenac, and the placebo suspensions were supplied in identical bottles labeled with a protocol and a patient number, so neither the investigators nor the patients were able to identify their contents.

The nepafenac, the bromfenac and the placebo eye drops were started 2 days before surgery. Patients have also received the same eye drops along 30 min just before surgery, three times 5 min apart. The treatment continued after surgery according the study protocol. If CME was detected at any time during the treatment period or beyond the scheduled 3-month follow-up period, topical treatment was given at the surgeon's discretion.

Surgical technique

One day before surgery, patients received a prophylactic, topical antibiotic (Moxifloxacin 0.3% eye drops) four times. One hour before surgery, pupils were dilated by topical instillation of a mixture of tropicamide 1%, cyclopentolate HCL 1%, and phenylephrine 2.5% every 15 min 2 h preoperative. Moreover, 2 ml of mepivacaine hydrochloride 3% as a retrobulbar injection or subtenon injection was used for local anesthesia.

All phacoemulsification operations were performed by the same, experienced surgeon following the standard procedure. Periocular skin sterilization was achieved by the application of povidone–iodine (betadine 10%) followed by instillation of 5% povidone–iodine solution in the conjunctival sac then irrigation of balanced salt solution after 1 min. The same, ophthalmic viscosurgical device (methylcellulose 0.2%) was used in all cases. In brief, phacoemulsification was performed through a 2.4-mm temporal clear corneal incision, and a foldable posterior chamber intraocular lens (Sensar AR40e; Abbott Medical Optics Inc. 1700 E. ST. ANDREW PL. SANTA ANA CA 92705) was implanted in the capsular bag.

Outcome measures

Primary outcome measures were the change in total and central macular thickness and the proportion of patients with macular swelling of at least 10 μm 3 months after surgery compared with baseline.

Secondary outcome measures were the change in total macular volume; the proportion of patient with macular swelling of at least 10 μm 3 months postoperative compared with baseline; VA, anterior segment inflammation, and ocular pain sensation during surgery and 24 h and 3 weeks postoperatively; ocular discomfort and photophobia one day postoperatively and during the 3 weeks treatment course; and intraoperative pupil dilatation measured with a caliper.

Adverse events were IOP changes versus baseline measured at day 1, 1 week, 1, 2, and 3 months after surgery and ocular or systemic signs with a relationship to the study regimens during the 3 months after surgery.

Statistical analysis

Data were entered into an excel spreadsheet (Microsoft Corp. Redmond, WA 98052-6399 USA) and analyzed using SPSS software (IBM SPSS Statistics Version 22.0; SPSS Inc., Chicago, Illinois, USA). The sample size was calculated from pilot study observations, accounting for a potential dropout rate of 10%. The sample size was based on the observed mean difference and the pooled standard difference from a previous study of bromfenac and nepafenac. A power of 80% and a confidence level of 95% yielded a sample size of 75 per arm. The primary null hypothesis was that there are no differences among bromfenac, nepafenac, and the control groups in the central subfield thickness. The alternative hypothesis was that bromfenac would have lower central subfield thickness than the two other groups (nepafenac and the placebo groups). Given the sample of at least 75 eyes, the study had almost 90% power to show the primary end point.

Quantitative variables are described using the mean ± SD or median as well as minimum and maximum values. The normality of data was assessed with the Shapiro–Wilk test. The paired t test was used to identify differences in means between groups and to investigate differences in preoperative–postoperative measures when normally distributed and the Wilcoxon test when continuous but not normally distributed. The qualitative variables were described with frequency distributions and compared using the Fisher exact test. Any differences showing a probability value (P value) of less than 0.05 (i.e. at the 5% level) was considered to be statistically significant. The analyses were performed using the full analysis set, which included all randomized patients who had at least two postoperative visits (1 and 6 weeks postoperatively).


  Results Top


A total of 93 patients were screened to participate in this study. Of them, 11 decided not to participate and seven fulfilled an exclusion criterion; thus, 18 were withdrawn from the analysis set. Therefore, 37 patients started the trial, received study medication, and were included in the full analysis set. Overall, 19 patients in the bromfenac group, 19 patients in the nepafenac group, and 37 patients in the placebo group completed all the protocol. There were no adverse effects in any of the three groups. Twenty-five (18.75%) were men and 50 (66.67%) were women. The mean age in the nepafenac group and the control group was higher than that in the bromfenac group, although the difference fell short of being statistically significant (P = 0.38). For this reason, the effect of age was tested in a logistic regression model analyzing one of the two main outcome measures. The age effect, however, was found to be negligible [Table 1]. [Table 1] shows the patient characteristics. [Table 2] shows the classification of cataract. There were no statistically significant differences in these parameters among the three study groups.
Table 1: The patient characteristics

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Table 2: The types of cataract

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The bromfenac group has less macular swelling than the nepafenac and the control groups, and the differences were statistically significant for primary and secondary outcome measures [Table 3] and [Table 4]. No CME developed in the bromfenac group (0.0%), one case was found in the nepafenac group (5.2%), and four cases were found in the control group (10.8%). They were given a round of combined bromfenac and dexamethasone three times a day at the surgeon's discretion after the study treatment phase and recovered completely by the 3-month follow-up.
Table 3: The foveal thickness in the three study group

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Table 4: Foveal volume (mm3) in the three study groups

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The CDVA improved significantly in all the three groups, from 0.1 to 0.6 (0.3–1) logMAR (at 1 month) in the bromfenac group, to 0.6 (0.2–1) logMAR at the nepafenac group (at 1 month), and to 0.3 (0.03–0.6) logMAR in the control group (at 1 month). Differences among the three groups were not statistically significant preoperatively (P = 0.110) but were statistically significant at 1 month postoperatively between the two groups that received NSAIDs and the control group (P = 0.001).

All groups had a statistically nonsignificant increase in the IOP from baseline to 1 month postoperatively (P = 0.372). The mean IOP increased from 15.21 ± 2.07 preoperatively to 15.42 ± 1.98 at one month postoperatively in the bromfenac group, from 14.16 ± 2.14 preoperatively to 14.58 ± 2.01 at 1 month postoperatively in the nepafenac group, and from 14.69 ± 1.82 preoperatively to 14.75 ± 1.73 in the control group at 1 month postoperatively.

The inferior parafoveal and perifoveal quadrants were the least to be affected by the increase in thickness postoperatively in all the three groups compared with the preoperative baseline values. The thickness of the inferior parafoveal quadrant (mm) increased from 228.26 ± 19.44 preoperatively to 252.74 ± 18.14 at 6 weeks postoperatively in the bromfenac group, from 233 ± 23.43 preoperatively to 254.05 ± 23.12 at 6 weeks postoperatively in the nepafenac group, and from 230.94 ± 25.08 preoperatively to 250.56 ± 23.97 at 6 weeks postoperatively in the control group. The differences among the three groups were not statistically significant preoperatively (P = 0.812) and at 6 weeks postoperatively (P = 0.874). The perifoveal thickness (mm) increased from 234.79 ± 13.34 preoperatively to 247.63 ± 16.11 at 6 weeks postoperatively in the bromfenac group, from 220.63 ± 23.68 preoperatively to 242.21 ± 25.53 at 6 weeks postoperatively in the nepafenac group, and from 215.56 ± 22.14 preoperatively to 234.56 ± 24.28 at 6 weeks postoperatively in the control group. There was no statistically significant difference between the bromfenac group and the nepafenac group preoperatively, but there was a statistically significant difference between the bromfenac group and the control group (P = 0.017). At 6 weeks postoperatively, there were statistically significant differences between the bromfenac group and the nepafenac group and between the bromfenac group and the control group (P = 0.003).

The superior parafoveal and perifoveal quadrants were the most to be affected by the increase in macular thickness postoperatively. The thickness of the superior parafoveal quadrant (mm) increased from 222.84 ± 19.66 preoperatively to 276.79 ± 14.51 at 6 weeks postoperatively in the bromfenac group, from 227.32 ± 25.10 preoperatively to 285.89 ± 21.28 at 6 weeks postoperatively in the nepafenac group, and from 224.5 ± 26.65 preoperatively to 294.63 ± 34.88 at 6 weeks postoperatively in the control group. The differences in thickness among the three study groups were not statistically significant preoperatively (P = 0.844) and at 6 weeks postoperatively (P = 0.106). The thickness of the perifoveal quadrant (mm) increased from 227.84 ± 16.71preoperatively to 274.89 ± 14.63 at 6 weeks postoperatively in the bromfenac group, from 209.16 ± 30.76 preoperatively to 267.21 ± 23.98 at 6 weeks postoperatively in the nepafenac group, and from 208.19 ± 29.10 preoperatively to 281 ± 23.91 at 6 weeks postoperatively in the control group. The differences in thickness among the three groups preoperatively were statistically significant (P = 0.044), but there were no statistically significant differences among the three groups at 6 weeks postoperatively (P = 0.164).

The thickness of the temporal parafoveal quadrant increased from 221.05 ± 16.93 preoperatively to 277.68 ± 22.54 at 6 weeks postoperatively in the bromfenac group, from 215.26 ± 31.55 preoperatively to 271 ± 27.90 at 6 weeks postoperatively in the nepafenac group, and from 204.31 ± 34.39 preoperatively to 274.13 ± 27.95 at 6 weeks postoperatively in the control group. There were no statistically significant differences among the three groups preoperatively (P = 0.233) and at 6 months postoperatively (P = 0.734). The thickness of the temporal perifoveal quadrant (mm) increased from 218.42 ± 34.20 preoperatively to 273.05 ± 34.36 at 6 weeks postoperatively in the bromfenac group, from 184.42 ± 56.03 preoperatively to 247.11 ± 39.59 at 6 weeks postoperatively in the nepafenac group, and from 163.75 ± 53.37 preoperatively to 242.94 ± 36.54 at 6 weeks postoperatively in the control group. There was no statistically significant difference between the bromfenac and the nepafenac groups preoperatively, but there was a statistically significant difference between the bromfenac group and the control group preoperatively (P = 0.006). At 6 weeks postoperatively, there were statistically significant differences among the three study groups (P = 0.036).

The thickness of the nasal parafoveal quadrant (mm) increased from 231.53 ± 18.88 preoperatively to 268.26 ± 16.24 at 6 weeks postoperatively in the bromfenac group, from 238.26 ± 23.69 preoperatively to 275.79 ± 25.52 at 6 months postoperatively in the nepafenac group, and from 236.31 ± 22.45 preoperatively to 286.06 ± 29.46 at 6 weeks postoperatively in the control group. There were no statistically significant differences among the three study groups preoperatively (P = 0.621) and at 6 weeks postoperatively (P = 0.102). The thickness of the nasal perifoveal quadrant (mm) increased from 233.58 ± 13.95 preoperatively to 259.58 ± 13.03 at 6 weeks postoperatively in the bromfenac group, from 215.16 ± 29.03 preoperatively to 239 ± 27.72 at 6 weeks postoperatively in the nepafenac group, and from 212.31 ± 23.33 preoperatively to 238.50 ± 30.66 at 6 weeks postoperatively in the control group. There were statistically significant differences between the bromfenac group and the nepafenac group and between bromfenac group and the control group preoperatively (P = 0.014) and at 6 weeks postoperatively (P = 0.017).


  Discussion Top


Pseudophakic macular edema, which is typically cystoid, is considered the most common cause of unfavorable visual decline after uneventful phacoemulsification, and it constitutes an important safety concern for this procedure because it can lead to permanent central vision decline[18]. Some recent studies have reported that incidence of clinically significant CME after phacoemulsification can be as high as 0.1–2.35%[20]. The purpose of this prospective randomized clinical trial was to evaluate the effectiveness of NSAIDs in preventing CME after uncomplicated cataract surgery and to specifically compare the effectiveness of two types of NSAIDs, nepafenac and bromfenac, for minimizing the incidence of pseudophakic CME.

In this clinical trial, there were no statistically significant differences in central subfield thickness and the macular volume between the bromfenac 0.09%, the nepafenac 0.1%, and the control group at 4 weeks postoperatively (P = 0.251 and 0.922, respectively), at 6 weeks after surgery (P = 0.075 and 0.924, respectively), and at 12 weeks after surgery (P = 0.182 and 0.942, respectively), in favor of bromfenac 0.09%.

In the current study, topical NSAIDs were used 2 days before the scheduled surgery, and it was found that following this regimen played a major role in minimizing the incidence of pseudophakic CME after uneventful phacoemulsification. Moreover, it was noticed that the addition of topical NSAIDs to the routine standard postcataract surgery corticosteroid regimen greatly decreased the incidence of postoperative CME. The incidence of CME, assessed by changes in OCT central macular thickening, was proved to be significantly different among the three study groups (P = 0.014). Clinical CME was not evident in the group that received bromfenac. On the contrary, the incidence of CME was 5.2% in the nepafenac group compared with 10.8% in the control group. A similar study by Sheppard[21] evaluated the efficacy of prophylactic bromfenac 0.07 or 0.09% versus a placebo to minimize the incidence of pseudophakic CME and the efficacy of bromfenac 0.07 or 0.09% as a treatment for acute or chronic postsurgical CME. The study suggested that bromfenac, either alone or in conjunction with corticosteroids, is effective for preventing pseudophakic CME.

Duong et al.[22], in a prospective, investigator-masked, randomized study, compared bromfenac 0.09% with prednisolone acetate 1% in patients undergoing phacoemulsification. Postoperative OCT did not detect any subclinical postoperative macular changes, falling outside 2 SD of the baseline OCT values or clinically significant CME in either of the two study groups. VA had improved in both groups postoperatively at day 1, 1 month, and remained stable at 2 months postoperatively.

The effects of bromfenac in minimizing the incidence of pseudophakic CME reported by this study are consistent with the results reported by a study conducted by Sheppard[21], studying the effect of using bromfenac, alone or in conjunction with the conventional postphacoemulsification steroid regimen, on OCT macular thickness values, followed throughout a period of 2 months after surgery. Sheppard[21] stated that the use of bromfenac alone or in conjunction with steroid regimen greatly minimized the increase in central retinal thickness and other markers of macular changes, compared with the use of corticosteroids alone or in conjunction with other NSAIDs.

According to Singh et al.[23], the use of nepafenac, starting one day preoperatively and continued for 90 days postoperatively had a statistically significant effect in the prevention of postoperative macular thickening compared with the control group. Overall, 16.7% of the patients developed macular thickening more than or equal to 30 μm in the control group compared with 2.4% in the nepafenac group. This study was conducted on 263 patients and was continued for 90-day follow-up period. According to Singh et al.[23], the use of nepafenac, starting one day preoperatively and continued for 90 postoperatively, had a statistically significant effect in the prevention of postoperative macular thickening compared with the control group. Overall, 16.7% of patients developed macular thickening more than or equal to 30 μm in the control group compared with 2.4% in the nepafenac group. This study was conducted on 263 patients and was continued for 90-day follow-up period.

Wolf et al.[14] have compared the efficacy of combining nepafenac 0.1% suspension and topical steroid as a postcataract anti-CME regimen for a period of 1 month after surgery, with the sole use of postoperative prednisolone eye drops for minimizing the incidence of clinically significant pseudophakic CME after uncomplicated phacoemulsification cataract extraction surgery for the same time period. They have postulated that there was a significantly higher incidence of clinically significant pseudophakic CME in those patients who have been receiving topical prednisolone only compared with the group of patients who have been receiving the combined prednisolone-nepafenac therapy.

According to Kessel et al.[24], using nonsteroidal eye drops for prevention of pseudophakic CME in 15 eyes assigned to phacoemulsification surgery for cataract extraction has shown that the incidence of pseudophakic CME was significantly higher in the group that received steroids compared with the NSAIDs group, with 25.3% of patients in the steroid group having experienced postoperative CME, compared with 3.8% in the NSAIDs group. The study compared the monotherapy use of steroids versus NSAIDs as a preventive treatment for pseudophakic CME after uncomplicated phacoemulsification surgery. High-risk factor patients were excluded, and the study has recommended the use of NSAIDs as an effective measurement to prevent pseudophakic CME. The sample upon which the study has been performed was too small, 15 eyes.

Tzelikis et al.[25] had reported that the use of prophylactic nepafenac was efficacious in guarding against the high incidence of pseudophakic CME compared with placebo, and there was no difference between the two groups regarding the final VA. In that study, pseudophakic CME had been reported in 3.57% of placebo group after 5 weeks following surgery, whereas no cases developed CME in the nepafenac group. A large study sample, 224 eyes of 112 patients with bilateral cataract, has been involved and followed up for up to 5 weeks postoperatively. Overall, 5.2% of the patients who received nepafenac have developed postsurgery CME compared with 10.8% of the patients in the control group, showing that nepafenac has greatly minimized the risk for postoperative CME compared with the control group. The differences between the results of this study and our study can be attributed to the different number of eyes involved in each of the two studies; the different concentrations of nepafenac eye drops used, being 0.1% in our study and 0.3% in the study by Tzelikis et al.[25]; and the short period of follow-up after surgery (5 weeks) compared with 3 months in our study.


  Conclusion Top


Starting the topical NSAIDs therapy 2 days before surgery has a major additive effect in minimizing the risk of pseudophakic CME after cataract surgery, and bromfenac has statistically surpassed nepafenac in minimizing the incidence of pseudophakic CME after phacoemulsification.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Shields MK, Adler PA, Fuzzard DR, Chalasani R, Teong JM. A case of acute bilateral Irvine-Gass syndrome following uncomplicated phacoemulsification, demonstrated with optical coherence tomography. Case Rep Ophthalmol 2015; 6:143–148.  Back to cited text no. 1
    
2.
Chu CJ, Johnston RL, Buscombe C, Sallam AB, Mohamed Q, Yang YC, et al. Risk factors and incidence of macular edema after cataract surgery: a database study of 81984 eyes. Ophthalmology 2016; 123:316–323.  Back to cited text no. 2
    
3.
Minnella AM, Savastano MC, Zinzanella G, Mazzone G, Federici M, Gari M, et al. Spectral-domain optical coherence tomography in Irvine–Gass syndrome. Retina 2012; 32:581–587.  Back to cited text no. 3
    
4.
Cho H, Wolf KJ, Wolf EJ. Management of ocular inflammation and pain following cataract surgery: focus on bromfenac ophthalmic solution. Clin Ophthalmol (Auckland, NZ) 2009; 3:199.  Back to cited text no. 4
    
5.
Colin J. The role of NSAIDs in the management of postoperative ophthalmic inflammation. Drugs 2007; 67:1291–1308.  Back to cited text no. 5
    
6.
Perry HD, Donnenfeld ED. An update on the use of ophthalmic ketorolac tromethamine 0.4%. Expert Opin Pharmacol 2006; 7:99–107.  Back to cited text no. 6
    
7.
El-Harazi SM, Feldman RM. Control of intra-ocular inflammation associated with cataract surgery. Curr Opin Ophthalmol 2001; 12:4–8.  Back to cited text no. 7
    
8.
Oka T, Shearer T, Azuma M. Involvement of cyclooxygenase-2 in rat models of conjunctivitis. Curr Eye Res 2004; 29:27–34.  Back to cited text no. 8
    
9.
Carreño E, Portero A, Galarreta DJ, Herreras JM. Update on twice-daily bromfenac sodium sesquihydrate to treat postoperative ocular inflammation following cataract extraction. Clin Ophthalmol (Auckland, NZ) 2012; 6:637.  Back to cited text no. 9
    
10.
Tajika T, Isowaki A, Sakaki H. Ocular distribution of difluprednate ophthalmic emulsion 0.05% in rabbits. J Ocul Pharmacol Ther 2011; 27:43–49.  Back to cited text no. 10
    
11.
Walters T, Raizman M, Ernest P, Gayton J, Lehmann R. In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac. J Cataract Refract Surg 2007; 33:1539–1545.  Back to cited text no. 11
    
12.
Kapin MA, Yanni JM, Brady MT, McDonough TJ, Flanagan JG, Rawji MH, et al. Inflammation-mediated retinal edema in the rabbit is inhibited by topical nepafenac. Inflammation 2003; 27:281–291.  Back to cited text no. 12
    
13.
Nowak J. Non-steroidal anti-inflammatory drugs (NSAIDs) in ophthalmology: pharmacological and clinical characteristics. Mil Pharm Med 2012; 5:33–50.  Back to cited text no. 13
    
14.
Wolf EJ, Braunstein A, Shih C, Braunstein RE. Incidence of visually significant pseudophakic macular edema after uneventful phacoemulsification in patients treated with nepafenac. J Cataract Refract Surg 2007; 33:1546–1549.  Back to cited text no. 14
    
15.
Schaudig, U, Scholz F, Lerche RC, Richard G. OCT bei Makulaödem. Ophthalmologe 2004; 101:785–793.  Back to cited text no. 15
    
16.
Biro Z, Balla Z, Kovacs B. Change of foveal and perifoveal thickness measured by OCT after phacoemulsification and IOL implantation. Eye 2008; 22:8–12.  Back to cited text no. 16
    
17.
von Jagow B, Ohrloff C, Kohnen T. Macular thickness after uneventful cataract surgery determined by optical coherence tomography. Graef Arch Clin Exp 2007; 245:1765–1771.  Back to cited text no. 17
    
18.
Tranos PG, Wickremasinghe SS, Stangos NT, Topouzis F, Tsinopoulos I, Pavesio CE. Macular edema. Surv Ophthalmol 2004; 49:470–490.  Back to cited text no. 18
    
19.
Packer M, Lowe J, Fine H. Incidence of acute postoperative cystoid macular edema in clinical practice. J Cataract Refract Surg 2012; 38:2108–2111.  Back to cited text no. 19
    
20.
Loewenstein A, Zur D. Postsurgical cystoid macular edema. Macular Edema 2010; 47:148–159.  Back to cited text no. 20
    
21.
Sheppard JD. Topical bromfenac for prevention and treatment of cystoid macular edema following cataract surgery: a review. Clin Ophthalmol (Auckland, NZ) 2016; 10:2099.  Back to cited text no. 21
    
22.
Duong HVQ, Westfield KC, Singleton IC. Treatment paradigm after uncomplicated cataract surgery: a prospective evaluation. Asia Pac J Ophthalmol (Phila) 2014; 3:220–225.  Back to cited text no. 22
    
23.
Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, et al. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol (Auckland, NZ) 2012; 6:1259.  Back to cited text no. 23
    
24.
Kessel L, Tendal B, Jørgensen KJ, Erngaard D, Flesner P, Andresen JL, et al. Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review. Ophthalmology 2014; 121:1915–1924.  Back to cited text no. 24
    
25.
Tzelikis PF, Morato CS, Neves NT, Hida WT, Alves MR. Intraindividual comparison of nepafenac 0.3% for the prevention of macular edema after phacoemulsification. J Cataract Refr Surg 2018; 44:440–446.  Back to cited text no. 25
    


    Figures

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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