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      Pseudophakic cystoid macular edema prevention and risk factors; prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo

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          Define the effectiveness of a topical non-steroidal anti-inflammatory drug (NSAID) added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema (PCME) using a prospective, randomized, double-masked, placebo-controlled clinical study.


          Eyes (1000) were randomized to placebo (497) or nepafenac 0.3% (503) used once daily, post-operatively for 5 weeks at two ophthalmology clinics. Diagnosis of PCME was made by clinical, ocular coherence tomography (OCT), and with fluorescein angiography confirmation. Correlation of PCME to NSAID use and the presence of pre-operative risk factors for PCME were assessed including, contralateral PCME, diabetic retinopathy, retinal vein occlusion, macular hole, epiretinal membrane, macular degeneration, retinal detachment repair, and prostaglandin use.


          PCME was the most common complication associated with routine cataract surgery (4.2% with PCME risk factors, 2.0% with risk factors excluded). Topical nepafenac 0.3% significantly reduces the incidence of PCME compared to placebo when used after routine cataract surgery ( p = .0001). When patients with pre-operative risk factors are excluded, the incidence of PCME between treatment and placebo groups is equivalent ( p = 0.31). PCME relative risk (RR) was most significant in contralateral PCME (RR 19.5), diabetic retinopathy (RR 13.1), retinal vein occlusion (RR 12.9), macular hole (RR 7.7), and epiretinal membrane (RR 5.7). Prostaglandin use and previous retinal detachment were not shown to increase risk.


          Pseudophakic cystoid macular edema is common after phacoemulsification cataract surgery. Topical nepafenac 0.3% reduces PCME in patients with pre-operative risk factors for PCME compared to placebo but shows no benefit in patients without pre-operative risk factors.

          Trial registration

          NIH ClincalTrials.gov retrospectively registered January 15, 2017, NCT03025945.

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          Most cited references 18

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          Associations between macular findings by optical coherence tomography and visual outcomes after epiretinal membrane removal.

           Min Suh,  Jong Seo,  Kyu Park (2009)
          To identify characteristics measured by optical coherence tomography (OCT) that are correlated with visual outcome after epiretinal membrane (ERM) removal by pars plana vitrectomy (PPV). Interventional, prospective, randomized case series. One hundred and one eyes of 101 patients with idiopathic ERM underwent PPV for ERM removal. Ophthalmic evaluations included best-corrected visual acuity (BCVA) and Stratus OCT preoperatively at 3 and 6 months postoperatively. Relations between three OCT features including integrity of junction between inner and outer segments of photoreceptors (IS/OS junction), macular thickness, foveal contour and the three visual acuity parameters such as preoperative BCVAs, postoperative BCVAs, and the differences between preoperative and postoperative BCVAs (BCVA differences) were evaluated with respect to time. Eyes with disruption of IS/OS junction had significantly lower postoperative BCVA and BCVA differences than those without disruption (P 0.25; P .05, respectively). Photoreceptor disruption detected by OCT was found to be a predictor of poor visual outcome in eyes with idiopathic ERM, and it was found that this disruption may be irreversible. Thus, early membrane removals may beneficially prevent further progression of photoreceptor damage in ERM patients with photoreceptor disruption.
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            Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment.

            To characterize the incidence, duration, and risk factors for and outcome of cystoid macular edema (CME) after cataract surgery and investigate the effects of treatment regimens on visual outcome and duration. University-based comprehensive ophthalmology practice. This study included 1659 consecutive cataract surgeries performed by residents between 2001 and 2006. Cases were classified according to the presence of CME. Subset analysis excluded patients with diabetes mellitus (DM). The CME groups were analyzed according to type of treatment to compare duration of CME and final best corrected visual acuity. The incidence of postoperative CME was 2.35% (39/1659), and history of retinal vein occlusion (RVO) was predictive of postoperative CME (odds ratio [OR], 47.12; P<.001). When patients with DM were excluded, the incidence of CME was 2.14% (29/1357) and history of RVO (OR, 31.75; P<.001), epiretinal membrane (ERM) (OR, 4.93; P<.03), and preoperative prostaglandin use (OR, 12.45; P<.04) were predictive of postoperative CME. Patients with DM and/or intraoperative complications did not have an increased risk for CME when treated with prophylactic postoperative nonsteroidal antiinflammatory drugs (NSAIDs) for 3 months. Groups treated with NSAIDs plus a steroid had significantly shorter resolution times than the untreated group (P = .004). A history of RVO, ERM, and preoperative prostaglandin use were associated with an increased risk for pseudophakic CME. Treatment with NSAIDs plus steroids was associated with faster resolution of CME than no treatment. Treating high-risk patients with NSAIDs after cataract surgery decreases the incidence of postoperative CME to that of patients who are not at high risk.
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              Risk Factors and Incidence of Macular Edema after Cataract Surgery

              To define the incidence of pseudophakic macular edema (PME) after cataract surgery and to identify contributory risk factors.

                Author and article information

                BMC Ophthalmol
                BMC Ophthalmol
                BMC Ophthalmology
                BioMed Central (London )
                20 February 2017
                20 February 2017
                : 17
                [1 ]Arizona Eye Consultants, 355 N. Silverbell Ave, Tucson, AZ 85745 USA
                [2 ]Retina Associates of Tucson, 6561 E. Carondelet Dr, Tucson, AZ 85710 USA
                [3 ]ISNI 0000 0001 2168 186X, GRID grid.134563.6, , University of Arizona, ; 6422 E. Speedway Ave, Tucson, AZ 85710 USA
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funded by: self funded by authors
                Research Article
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                © The Author(s) 2017

                Ophthalmology & Optometry


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