Eyeworld

SEP 2014

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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EW RESIDENTS 84 September 2014 As the most common cause of decreased vision after cataract surgery, CME continues to be a challenge for clinicians to manage and prevent. There is good evidence in the literature regarding the use of NSAIDs in treating PCME, as well as suggesting topical NSAIDs as being more effi cacious than steroids alone at controlling postoperative infl am- mation and PCME. However, there is still much in question regarding specifi c types of NSAIDs and wheth- er or not combination NSAID/ steroid therapy should be a preferred pattern of practice. In this study, the authors concluded that the com- bination of nepafenac and dexa- methasone reduced CME and may be benefi cial postoperatively, which supports prior studies on the utility of NSAIDs in cataract surgery. While the prospective double- masked, randomized study design lends strength to the results, one weakness is that the authors did not perform a true intent-to-treat analysis. There were a total of 160 patients but only 152 were includ- ed in the analyses; reasons for not including the other 8 patients were because 3 patients in the control groups exited the study prematurely, and 5 patients in the actively treated group were withdrawn because of unforeseen operative complica- tions including retained cortical remnants, loose zonules, improper dosing of study medication, use of non-allowed medicine, and "ap- pearance of general health problems judged to be unrelated to study treatments." These 5 purposefully excluded patients were all from the actively treated group. While the study question was to specifi cally address infl ammation and macu- lar thickness in low-risk patients, removing enrolled patients after ran- domization because of unpredictable events takes away from the strength of this prospective study. Moreover, there are limitations to the interpretations of the study's results. While the study alludes to the potential benefi t of combination nepafenac/dexamethasone therapy this prospective double-masked, randomized study, 160 patients were divided into two groups: the control group with 0.1% dexamethasone and placebo (artifi cial tears) and the study group with 0.1% dexametha- sone plus nepafenac 0.1%. All drops were administered 3 times daily for 3 weeks after the surgery, while the placebo and nepafenac were started 2 days prior to surgery and given 3 times in the immediate preoperative period 5 minutes apart. The authors used Stratus time domain optical coherence tomography (TD-OCT) to evaluate the change of total mac- ular volume (TMV) as well as the proportion of patients with macular swelling (defi ned by the authors as swelling of at least 10 µm) at 6 weeks following cataract extraction. Secondary outcomes focused on anterior chamber infl ammatory response (using laser-fl are photom- etry), best corrected visual acuity (BCVA) with ETDRS eye meter chart, subjective complaints of discom- fort and photophobia, and ocular adverse events. Of the enrolled patients, 2 developed CME in the control population while none developed CME in the study population (p=0.5099). The authors found that the nepafenac group demonstrated signifi cantly less change in TMV, and there was a signifi cantly less proportion of patients with macular swelling of at least 10 µm in the 3 weeks and 6 weeks after surgery compared to the control group. In the nepafenac plus dexamethasone group, there was also signifi cantly decreased aqueous fl are (p=0.0285) on day 1, decreased pain and photo- phobia on postop day 1 (p<0.0001, p=0.0155, respectively) and week 3 (p=0.0058, p=0.0052, respective- ly). However, the nepafenac group also showed more corneal fl uores- cein staining compared to control (p=0.0119). There was no signifi cant statistical difference in BCVA, which was found to improve signifi cant- ly in both populations following cataract surgery, between the study groups. Review of "Nepafenac 0.1% plus dexamethasone alone and effect on macular swelling after cataract by Jaya Kumar, MD, Nambi Nallasamy, MD, Wenlan Zhang, MD, ophthalmology residents, and Pratap Challa, MD, residency program director, Duke Eye Center Nepafenac 0.1% plus dexamethasone 0.1% versus dexamethasone alone and effect on macular swelling after cataract surgery Anna Zaczek, MD, PhD, Ditte Artzen, MD, Carl-Gustaf Laurell, MD, PhD, Ulf Stenevi, MD PhD, Per Montan, MD, PhD J Cataract Refract Surg (Sept.) 2014;40:1498–1505 Purpose: To evaluate the effi cacy of added 0.1% nepafenac ophthalmic suspension to 0.1% dexamethasone eye drops in controlling postoperative macular swelling and other manifestations of infl ammation after uncomplicated cataract surgery. Setting: Ophthalmology Department, Mölndal Hospital and St. Erik Eye Hospital, Stockholm, Sweden. Design: Prospective randomized double-masked controlled clinical trial. Methods: Patients at low risk for postoperative infl ammation were recruited. Postoperative swelling of the macula was assessed with ocular coherence tomography (OCT). Laser fl are intensity, best corrected visual acuity (BCVA), ocular discomfort, and visual complaints were also recorded. Results: One hundred sixty patients were randomized; 75 patients in the nepafenac group and 77 patients in the control group were included in the intent-to-treat population. In comparison to the control regimen, add-on nepafenac resulted in statistically signifi cant reductions in the following parameters: change in macular volume at 3 and 6 weeks (P<.001), proportion of patients with more than 10 µm swelling in the central macula at 3 weeks (P<.0001) and at 6 weeks (P=.02) after the operation, mean laser fl are intensity 1 day after surgery (P=.029), pain during the fi rst 24 hours postoperatively (P<.0001), ocular discomfort and photophobia during the fi rst 3 postoperative weeks (P=.0058 and P=.0052, respectively). Conclusion: The combination of topical nepafenac and steroid treatment provided reduction of subclinical macular swelling, infl ammation, and subjective complaints and holds promise as an effi cient anti-infl ammatory regimen after cataract surgery. Financial disclosure: No author has a fi nancial or proprietary interest in any material or method mentioned. I n the article "Nepafenac 0.1% plus dexamethasone 0.1% versus dexamethasone alone and effect on macular swelling after cataract surgery," Zaczek et al. attempt to elucidate whether combination preoperative topical nonsteroidal anti-infl ammatory drug (NSAID) and steroid use could decrease the incidence of postoper- ative cystoid macular edema (CME) in low-risk patients. While many cataract surgeons have adopted the use of pre- and postoperative topical NSAIDs into their practice, no gold standard anti-infl ammatory regimen has been established for prophylaxis against pseudophakic cystoid macular edema (PCME). In Pratap Challa, MD, residency program director, Duke Eye Center The question of whether both topical NSAIDs and steroids are necessary following routine cataract surgery continues to be debated. I asked the Duke residents to review this random- ized prospective study appearing in this month's JCRS. –David F. Chang, MD, chief medical editor EyeWorld journal club

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