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• W2146087831 abstract "There are promising reports in literature suggesting that newer generation triazole agents like voriconazole may overcome the significant shortcomings of commonly used antifungals such as poor ocular penetration, fungistatic nature, drug stability, lack of broad-spectrum coverage, and suboptimal aqueous concentration.1Reis A. Sundmacher R. Tintelton K. Successful treatment of ocular invasive mould infection (fusariosis) with the newer antifungal voriconazole.Br J Ophthalmol. 2000; 84: 932-933Crossref PubMed Scopus (106) Google Scholar, 2Bunya V. Hammersmith K. Rapuano C. et al.Topical and oral voriconazole in the treatment of fungal keratitis.Am J Ophthalmol. 2007; 143: 151-153Abstract Full Text Full Text PDF PubMed Scopus (94) Google Scholar, 3Granados J.M. Puerto N. Carrilero M.J. Efficiency of voriconazole in fungal keratitis caused by candida albicans.Arch Soc Esp Oftalmol. 2004; 79: 565-568Crossref PubMed Google Scholar, 4Stewart R. Quah S.A. Neal T.J. Kaye S.B. The use of voriconazole in treatment of Aspergillus fumigatus keratitis.Br J Ophthalmol. 2007; 91: 1095-1096Crossref Scopus (7) Google Scholar To the best of our knowledge, no study has compared efficacy of voriconazole with conventional antifungal treatment in severe keratomycosis, in a prospective randomized clinical trial. In this prospective randomized study, we compared the efficacy of oral and topical voriconazole with that of conventional antifungal treatment. We prospectively included 45 eyes of 45 patients having severe fungal corneal ulcer (Table 1; available at http://aaojournal.org) and randomly divided them into 3 groups (restricted to 15 patients each): Group I received oral and topical voriconazole 1%, group II received oral voriconazole and topical natamycin 5% suspension, and group III received oral itraconazole and topical natamycin 5% suspension (Table 2; available at http://aaojournal.org). Primary outcome measures were time to resolution of epithelial defect, infiltrates, and hypopyon (if present). Secondary outcome measures were nature of corneal opacity and best corrected visual acuity at the end of 3 months after enrollment. Predisposing risk factors at baseline were noted in 34 (75.5%) eyes (Table 3; available at http://aaojournal.org). The most common risk factor noted was trauma to cornea in 23 (51.1%) eyes. Organisms were isolated in 17 (37.8%) eyes through culture. We isolated Fusarium solani in 6 (13.3%) eyes, Aspergillus flavus in 5 (11.1%) eyes, Aspergillus niger in 3 (6.6%) eyes, Curvularia lunata in 2 (4.4%) eyes, and Acremonium spp in 1 (2.2%) eye (Table 4; available at http://aaojournal.org). The mean time for disappearance of hypopyon was 9.8±1.7, 12.3±3.6, and 16±10.52 days in groups I, II, and III respectively (P = 0.231). The mean time of resolution of infiltrates was 36.8±10.66, 38.81±8.94, and 36.7±10.42 days in groups I, II, and III respectively (P = 0.860). The mean time of closure of epithelial defect was 31.1±11.4, 29.18±8.25, and 31.8±11.4 days in group I, II, and III respectively (P = 0.837) (Table 5; available at http://aaojournal.org). At the end of 3 months, treatment success was achieved in 10 eyes (66.7%) in group I, 11 eyes (73.3%) in group II, and 10 eyes (66.7%) in group III respectively (P = 0.902). We did not note any significant difference in the incidence of complications including corneal perforation between the 3 groups (Table 6; available at http://aaojournal.org). In our study, we found a comparable rate of healing of epithelial defects and infiltrates in all the groups. Although not statistically significant, we observed a faster rate of resolution of hypopyon in patients receiving oral and topical voriconazole. At the end of 3 months, leukomatous corneal opacity was observed in 9 (60%), 11 (73.3%), and 9 (60%) eyes in group I, II, and III respectively (P = 0.4). Also, improvement in visual acuity in healed subjects was similar in the study groups and depended on the location of the corneal opacity and its relation with the visual axis (Table 7; available at http://aaojournal.org). In our study, logistic regression analysis identified age ≥45 years (95% confidence interval [CI], 1.15–60; P = 0.036) and epithelial defect area ≥36 mm2 (95% CI, 2.56–151.49; P = 0.004) as the most significant risk factors for primary treatment failure in severe keratomycosis (Table 8; available at http://aaojournal.org). Although not statistically significant, we also found presence of hypopyon at baseline in all patients with treatment failure. One study identified ulcer size greater than 14 mm2, presence of hypopyon and growth of Aspergillus species as the risk factors for poor treatment outcome in fungal keratitis treated with 5% natamycin monotherapy.5Prajna L. Namperumalsamy V.P. Kabra A. et al.Risk factors for treatment outcome in fungal keratitis.Ophthalmology. 2006; 113: 526-530Abstract Full Text Full Text PDF PubMed Scopus (90) Google Scholar In our study, 4 of the 5 fungal ulcers caused by Aspergillus species responded well to voriconazole treatment. Thus, voriconazole may offer better efficacy compared with conventional antifungal drugs against corneal ulcers caused by Aspergillus species. This is the first prospective randomized study on the role of voriconazole in treatment of fungal corneal ulcers. We found voriconazole effective and well-tolerated drug in treatment of severe keratomycosis. Further studies with a larger sample size might be helpful to establish voriconazole as a first line of treatment in keratomycosis. Table 1Inclusion and Exclusion CriteriaInclusion Criteria 1Ulcer with epithelial defect more than 5 mm in the greatest dimension.2Infiltrates involving more than 2/3 depth of corneal thickness.3Proven fungal corneal ulcer either on 10% potassium hydroxide (KOH) wet mount/Calcoflour white stain (CFW) or growth of fungi on Sabouraud's dextrose agar (SDA).4Age older than 18 yrs5Willingness to be treated as an in-patient or to be treated as an out-patient and follow up every 48 hours to receive fresh medications.Exclusion criteria 1Perforated corneal ulcer or impending corneal perforation2Sclera involvement3Total corneal involvement4Endophthalmitis5Acanthamoeba keratitis6Evidence of bacteria on Gram stain at the time of enrollment7Evidence of herpetic keratitis by history or examination8Bilateral ulcers9Previous history of any ocular surgery in the affected eye10Pregnancy (by history or urine test) or breast-feeding (by history)11Known allergy to study medications (antifungal or preservative)12No light perception in the affected eye13Patient with hepatic or renal disease or deranged liver function test and14Patients who failed to complete follow up of 3 months. Open table in a new tab Table 2Randomization of PatientsAll the Patients were Randomly Divided into 3 Groups (Restricted to 15 Patients each) for Treatment:Group I: Tablet voriconazole 400 mg twice a day on day 1 followed by 200 mg twice daily thereafter and topical voriconazole 1% 1 hourly.Group II: Tablet voriconazole 400 mg twice a day on day 1 followed by 200 mg twice daily thereafter and topical natamycin 5% suspension 1 hourly.Group III: Tablet itraconazole 200 mg twice daily and topical natamycin 5% suspension 1 hourly. * In all 3 groups, oral antifungal treatment was continued till the resolution of infiltrates whereas topical antifungals 1%, 1 drop applied to the affected eye every 1 hour while awake for 1 week, then every 2 hours while awake untill healing of epithelial defect and then gradually tapering it off. * Patients were followed every 48 to 72 hours till epithelial defect healed and thereafter every 1 week for 1 month then every 2 weekly for next month and last visit was at the end of 3 month. * Treatment success was defined as resolution of the corneal infiltrate with scarring, disappearance of the corneal endothelial plaque and hypopyon, and closure of the epithelial defect. * Treatment failure was considered if the infiltrate and/or epithelial defect increase by 2 mm or more in size or increase in the size of hypopyon or endothelial plaque continued to enlarge for 3 consecutive days or perforation. Open table in a new tab Table 3Distribution of Risk Factors Between the Groups at BaselineGroupRisk FactorsI (n = 15)II (n = 15)III (n = 15)Total (n = 45)PTrauma6 (40%)9 (60%)8 (53.3%)23 (51.1%)0.3Diabetes1 (6.7%)1 (6.7%)3 (20%)5 (11.1%)0.4Lid abnormalities1 (6.7%)1 (6.7%)02 (4.4%)0.5Previous ocular surgery2 (13.3%)002 (4.4%)0.1Steroid exposure1 (6.7%)01 (6.7%)2 (4.4%)0.6Nil4 (26.7%)4 (26.7%)3 (20%)11 (24.4%)0.8 Open table in a new tab Table 4Distribution of Baseline Culture Isolates Between the GroupsGroupOrganismI (n = 15)II (n = 15)III (n = 15)TotalPAcremonium spp001 (6.7%)1 (2.2%)0.4Aspergillus spp4 (26.7%)1 (6.7%)3 (20%)8 (17.8%)0.7Curvularia spp1 (6.7%)1 (6.7%)02 (4.4%)0.3Fusarium spp2 (13.3%)1 (6.7%)3 (20%)6 (13.3%)0.8No organism cultured8 (53.3%)12 (80%)8 (53%)28 (62%)0.2 Open table in a new tab Table 5Outcome MeasuresGroupNMean ± SD (days)Minimum (days)Maximum (days)Time of disappearance of hypopyon (days)⁎The mean pretreatment infiltrate area, epithelial defect, and height of hypopyon were comparable in all the groups.I69.8±1.7712II1012.3±3.6618III816±10.51041Total2412.9±6.7641Time of resolution of infiltrate (days)⁎The mean pretreatment infiltrate area, epithelial defect, and height of hypopyon were comparable in all the groups.I1036.8±10.62055II1138.8±8.92851III1036.7±10.41752Total3137.4±9.71755Time of closure of epithelial defect (days)⁎The mean pretreatment infiltrate area, epithelial defect, and height of hypopyon were comparable in all the groups.I1031.1±11.41655II1129.2±8.22145III1031.8±11.41550Total3130.6±10.11555 The mean pretreatment infiltrate area, epithelial defect, and height of hypopyon were comparable in all the groups. Open table in a new tab Table 6Complications Between the GroupsGroup IGroup IIGroup IIITotalPCataract2 (13.3%)2 (13.3%)1 (6.6%)5 (11.1%)0.7Perforation5 (33.3%)4 (26.6%)5 (33.3%)14 (31.1%)0.9Glaucoma1 (6.6%)01 (6.6%)2 (4.4%)0.5Endophthalmitis01 (6.6%)01 (2.2%)0.3Phthisis bulbi01 (6.6%)01 (2.2%)0.3 Open table in a new tab Table 7Comparison of Pre- and Post-Treatment Visual Acuity Between the 3 GroupsGroupNMean ± SDMinimum(logMAR)Maximum(logMAR)Initial visual acuity (logMAR)I153.1±1.061.04II152.5±0.91.34III152.2±1.040.74Total452.6±1.050.74Final visual acuity (logMAR)I151.7±0.90.74II151.5±0.80.74III151.2±0.60.63Total451.4±0.80.64logMAR = logarithm of the minimum angle of resolution; SD = standard deviation. Open table in a new tab Table 8Predictor Factors for Treatment Failure in Severe Keratomycosis95% CIFactorsN (%)Odds RatioLowerUpperPAge (yrs) <45248.3451.15160.5000.036 ≥4521Organisms Present175.250.82133.5640.08 Absent28Trauma Present233.270.47922.3070.227 Absent22Epithelial defect <36 sq mm3319.7092.564151.4950.004 ≥36 sq mm12CI = confidence interval. Open table in a new tab logMAR = logarithm of the minimum angle of resolution; SD = standard deviation. CI = confidence interval." @default.
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• W2146087831 title "Voriconazole for Fungal Corneal Ulcers" @default.
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