Abstract
Introduction: Cataract is the most common surgical procedure. Study was done to compare the effect of nepafenac 0.1% plus prednisolone 1% vs prednisolone 1% alone in controlling ocular inflammation after phacoemulsification
Material and Methods: A total of 140 patients were randomized to receive prednisolone 1% (group I) vs nepafenac plus prednisolone 1% (group II) after uneventful phacoemulsification. Patients were examined on first day, one week and one month for vision, slit lamp evaluation for anterior segment inflammation and cystoid macular edema.
Results: Average visual acuity was 6/9 in both groups. Anterior segment inflammation was significantly less in group II on first post-operative day. On later visits, there was no significant difference in inflammation in both groups. CME was not seen in any group.
Conclusion: This study suggests that addition of nepafenac 0.1% to prednisolone 1% significantly reduces the intraocular inflammation after phacoemulsification in the early postoperative period.
Keywords: Nepafenac; Prednisolone; Iritis; Phacoemulsification
Abbreviations: IOP: Intra-Ocular Pressure; NSAIDs: Non-Steroidal Anti-Inflammatory Drops; CME: Cystoid Macular Edema; IOL: Intra-Ocular Lens; BCVA: Best-Corrected Visual Acuity; SUN: Standardization of Uveitis Nomenclature
Introduction
Cataract surgery is one of the most common and most effective surgical procedure performed worldwide [1]. After the surgery, it is also the postoperative care of the patients that determines a good outcome. The routine postoperative care after cataract surgery consists of prevention of infection and prevention of inflammation. Broad-spectrum antibiotics like moxifloxacin eye drops are the mainstay for prevention of infection. Steroids like prednisolone are most potent for prevention of inflammation [2,3]. Inflammation is caused by the release of arachidonic acid that subsequently forms prostaglandins, the main inflammatory mediator [4,5]. Steroids inhibit arachidonic acid release by inhibiting the enzyme phospholipase A2, thereby decreasing the synthesis of all prostaglandins, thromboxanes and eicosanoids [6,7]. However, steroid use can lead to elevation of intraocular pressure and an increased risk of infection [8]. Therefore, several non-steroidal anti-inflammatory drops (NSAIDs) are increasingly being used to prevent post-operative inflammation and cystoid macular edema (CME) [7,9,10]. NSAIDs inhibit prostaglandin release through inhibition of cyclo-oxygenase enzyme that catalyzes the conversion of arachidonic acid to prostaglandins [6,7,9]. Studies have compared various NSAIDs with steroids and have found them to be equally effective and safer in controlling inflammation [11,12]. NSAIDs are also found to be better than steroids for corneal and limbal wound healing [13,14]. However, their role as an add-on treatment to steroids is still debated. We conducted a prospective study to compare whether addition of nepafenac to the routine antibiotic and steroid regimen had
Material and Methods
This was a prospective randomized control study done from March 2023 to April 2024 in upgraded department of ophthalmology at Government Medical college Jammu, India. A total of 280 patients who were > 50 years of age and operated for cataract without any intraoperative complications were included in the study. Patients with any pre-existing ocular or systemic illness like corneal opacity, glaucoma, uveitis, complicated cataract, macular pathology, trauma, diabetes or arthritis were excluded. Pre-operatively, thorough clinical examination including vision, intra-ocular pressure (IOP) measurement by applanation tonometry, slit lamp examination for anterior segment and fundus examination was done for all patients. Written informed consent was taken from all patients prior to surgery. Phacoemulsification was done and intra-ocular lens (IOL) was implanted in all. Patients were randomly distributed in two groups by simple randomization. In the first group, patients were given moxifloxacin 0.5% drops 4 times/day for 2 weeks and Prednisolone 1% drop 4 times/day for 1 week followed by gradual tapering over next 3 weeks. In the second group, in addition to the medications given in group I, patients were also given nepafenac 0.1% eye drops thrice a day for 4 weeks. Post-operatively patients were examined on day 1, day 7 and 1 month. On each visit, best-corrected visual acuity (BCVA) was noted, anterior segment was examined on slit-lamp for presence of cells, flare and posterior segment was examined for presence of CME. Anterior segment inflammation was graded in accordance with standardization of uveitis nomenclature (SUN) working group classification:14 None- 50 cells, fixed and plastic iris.
Statistical Analysis
Statistical analysis was done using SPSS software version 20.0. Quantitative data was analyzed using independent sample t-tests and qualitative data was analyzed using chi square test. Alpha error of p<0.05 was considered significant.
Results
There were 140 patients in each group. The mean age of patients in group I was 65.24 years and group II were 64.68 years (P= 0.57). In group I, there were 40 males and 30 females while in group II, there were 42 males and 28 females (P=0.73). The average BCVA of patients in both groups was 6/9. On slit lamp examination on day 1, 24 patients in group I and 8 patients in group II had iritis (P=0.03). On day 7, 6 patients (4.2%) in group I and 2 patients (1.4%) in group 2 had iritis (P= 0.31). On day 30, none of the patients in both groups had iritis. None of the patients in both groups developed CME on clinical fundus evaluation.
Discussion
The groups were comparable in terms of age and gender. Average visual acuity was same in both the groups, implying that addition of nepafenac did not change the visual outcome. Anterior segment inflammation on postoperative day 1 was significantly less in the nepafenac plus prednisolone group (group II) compared to prednisolone alone group (p=0.03). On day 7, 3 patients in prednisolone alone group and 1 in nepafenac plus prednisolone group had iritis, though the difference was not statistically significant (p=0.31). Zaczek et al [15] had compared nepafenac plus dexamethasone vs dexamethasone alone and had also found that addition of nepafenac reduced inflammation and subjective complaints [15]. There are other studies which have compared steroid alone with NSAIDs alone and have found NSAIDs to be equally effective in reducing inflammation [11,12,16,17]. In addition, studies have reported that NSAIDs decrease the chances of macular edema post cataract surgery [18,19]. Wittpenn et al [20] compared ketorolac plus steroid vs steroid alone and found that adding ketorolac significantly decreases the incidence of CME [20]. However, in this study, CME on clinical examination A2 was not found in any group, so comparison could not be done on this aspect. The limitation of our study is that comparison was done on the basis of only the clinical signs. Further studies, with a larger sample size, and detecting CME using optical coherence tomography can be done.
Conclusion
This study suggests that addition of nepafenac 0.1% to prednisolone 1% significantly reduces the intraocular inflammation after phacoemulsification in the early postoperative period.
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