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      Topical nepafenac 0.1% alone versus prednisolone acetate 1% as postoperative anti-inflammatory agents in small gauge vitrectomy

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          Abstract

          Aim:

          To compare the efficacy of postoperative topical nepafenac (0.1%) with prednisolone acetate (1%) as anti-inflammatory agents in eyes undergoing Transscleral Sutureless Vitrectomy (TSV).

          Settings and Design:

          Prospective, double-blind, randomized, single center clinical study.

          Materials and Methods:

          Eighty eyes of 76 subjects, who underwent small gauge vitrectomy, were included in the study. The subjects who fulfilled the inclusion criteria were randomized to either topical nepafenac only (Group 1) or prednisolone acetate only (Group 2), to be used as postoperative anti-inflammatory agents. The subjects were reviewed on days 1, 30, and 90. Ocular and adnexal inflammation was appropriately graded using the standardized classification. Grading of ocular pain was done on the Visual Analog Scale (VAS).

          Statistical Analysis:

          The Wilcoxon rank-sum test, using two-sided analysis, was used.

          Results:

          During the follow-up, both Group 1 and Group 2 did not have a significant difference related to the grade of the anterior chamber inflammation ( P > 0.05) or adnexal inflammation ( P > 0.05). Pain perception was less in the subjects in Group 1 as compared to subjects in Group 2, but was not statistically significant ( P > 0.05).

          Conclusion:

          Postoperative topical nepafenac was non-inferior to prednisolone acetate in reducing postoperative ocular inflammation in eyes undergoing TSV.

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          Most cited references19

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          Medical prophylaxis and treatment of cystoid macular edema after cataract surgery. The results of a meta-analysis.

          The study aimed to determine the effectiveness of prophylactic medical intervention in reducing the incidence of cystoid macular edema (CME) and the effectiveness of medical treatment for chronic CME after cataract surgery. The study design was a systematic review and meta-analysis of published reports of randomized clinical trials (RCTs). Sixteen RCTs involving 2898 eyes examining the effectiveness of medical prophylaxis of CME and 4 RCTs involving 187 eyes testing the effectiveness of medical treatment of chronic CME were used in the study. Medical prophylaxis of treatment (cyclo-oxygenase inhibitors or corticosteroids) versus control (placebo or active treatment) was performed. Incidence of angiographically diagnosed CME, incidence of clinically significant CME, and vision were measured. Thirty-six articles reported testing a prophylactic medical intervention for CME after cataract surgery. The incidence of CME varied extensively across studies and was related to the study design used. Summary odds ratios (OR) indicated that prophylactic intervention was effective in reducing the incidence of both angiographic CME (OR = 0.36; 95% confidence interval [CI] = 0.28-0.45) and clinically relevant CME (OR = 0.49; 95% CI = 0.33-0.73). There also was a statistically significant positive effect on improving vision (OR = 1.97; 95% CI = 1.14-3.41). A combination of the results of the four RCTs testing medical therapy for chronic CME indicated a treatment benefit in terms of improving final visual acuity by two or more Snellen lines (OR = 2.67; 95% CI = 1.35-5.30). Assessment of the quality of the 20 RCTs included in the meta-analyses indicated problems in the design, execution, and reporting of a number of trials. A combination of the results from RCTs indicates that medical prophylaxis for aphakic and pseudophakic CME and medical treatment for chronic CME are beneficial. Because most of the RCTs performed to date have problems related to quality, a well-designed RCT is needed to confirm this result, using clinical CME and vision as outcomes.
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            Topical nonsteroidal anti-inflammatory drugs for ophthalmic use: a safety review.

            Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used agents that despite chemically heterogeneity, share similar therapeutic properties and adverse effects. Topical ophthalmic NSAIDs are limited to the relatively water soluble phenylacetic and phenylalkanoic acids as well as indole derivatives, which are more suitable for ophthalmic use. Topical ophthalmic NSAIDs are commonly used in the treatment of post-operative inflammation following cataract extraction and various surgical refractive procedures. They are also used in the prevention and treatment of cystoid macular oedema and for the treatment of allergic conjunctivitis. Absorption of topical ophthalmic NSAIDs through the nasal mucosa results in systemic exposure and the occurrence of adverse systemic events, including exacerbation of bronchial asthma. Local irritant effects of topical ophthalmic NSAIDs include conjunctival hyperaemia, burning, stinging and corneal anaesthesia. A more serious complication involves the association of topical ophthalmic NSAIDs with indolent corneal ulceration and full-thickness corneal melts. Analysis of NSAID-associated corneal events implicates the now defunct generic dicolfenac product, diclofenac sodium ophthalmic solution as the agent primarily responsible. However, these events generated a renewed interest in the safety of ophthalmic NSAIDs and a scrutiny of the pharmacology regarding NSAID action in the eye. An elucidation of possible pharmacodynamic explanations of NSAID-induced corneal injury includes the role of epithelial hypoxia, which not only appears to aid in determining the metabolic destination of arachidonate, it may play a key role in orchestrating a novel inflammatory response unrelated to prostanoid formation. The use of NSAIDs under conditions of corneal hypoxia may therefore not only result in a disappointing therapeutic response, it may result in a paradoxical inflammatory exacerbation. Other potential mechanisms include the relationship between NSAIDs and corneal matrix metalloproteinase and direct toxicity due to cytotoxic excipients such as surfactants, solubilisers and preservatives found in topical NSAID ophthalmic preparations. In general, ophthalmic NSAIDs may be used safely with other ophthalmic pharmaceuticals; however, concurrent use of agents known to adversely effect the corneal epithelium, such as gentamicin, may lead to increased corneal penetration of the NSAID. The concurrent use of NSAIDs with topical corticosteorids in the face of significant pre-existing corneal inflammation has been identified as a risk factor in precipitating corneal erosions and melts and should be undertaken with caution. Until clinical evidence dictates otherwise, data supporting theories of potential pharmacodynamic mechanisms of NSAID injury do not alter the favorable benefit-risk ratio of ophthalmic NSAID use when employed in an appropriate and judicious manner.
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              Nepafenac 0.1% versus fluorometholone 0.1% for preventing cystoid macular edema after 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.
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                Author and article information

                Journal
                Indian J Ophthalmol
                Indian J Ophthalmol
                IJO
                Indian Journal of Ophthalmology
                Medknow Publications & Media Pvt Ltd (India )
                0301-4738
                1998-3689
                May 2014
                : 62
                : 5
                : 606-609
                Affiliations
                [1]Department of Retina and Vitreous, Retina Foundation, Rajbhavan Road, Ahmedabad, Gujarat, India
                Author notes
                Correspondence to: Dr. Manish Nagpal, Retina Foundation, Near Shahibaug underbridge, Rajbhavan road, Ahmedabad - 380 004, Gujarat, India. E-mail: drmanishnagpal@ 123456yahoo.com
                Article
                IJO-62-606
                10.4103/0301-4738.129781
                4065514
                24881610
                5415c6a2-325e-4d00-a122-de26c82f5b75
                Copyright: © Indian Journal of Ophthalmology

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 16 March 2013
                : 15 September 2013
                Categories
                Original Article

                Ophthalmology & Optometry
                inflammation,nepafenac,non-steroidal anti-inflammatory drugs,prednisolone,transscleral sutureless vitrectomy

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