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Published byArchibald Dorsey Modified over 9 years ago
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None of the authors have any financial interests nor was the study supported by any unrestricted grant from government or non government agencies.
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Purpose – To objectively compare the efficacy of three pharmacological regimen post cataract extraction Design – IRB approved, prospective, randomized, single-blind study conducted at a single center, private, teaching practice in Las Vegas, Nevada. – Three variables (end points) were measured Degree of intraocular spike Degree anterior chamber inflammation Incidence of cystoid macular edema
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Methods – Patients were randomized into three groups Control: gatifloxacin 0.3%, prednisolone acetate 1%, and bromfenac 0.09% (N = 41) Group I: gatifloxacin 0.3% and bromfenac 0.09% (N = 40) Group II: one intraoperative Triamcinolone acetonide injection, gatifloxacin 0.3% and bromfenac 0.09% (N = 30) – Pre-operative evaluation included a comprehensive dilated eye exam and base line OCT – Post-operative IOP and AC inflammation data were collected at 1-day, 1-week and 1-month for. OCTs were ordered at 1 week and 1 month – All surgeries were performed by one surgeon. All IOP measurements & OCT scans were performed by one certified tech
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Results: Intraocular Pressure – Studied Population – Greatest IOP flux occurred on post-op day-1 Control & Group II – highest spike (7 & 6 mmHg) from baseline Group I: smallest spike (3 mmHg) and not statistically significant (p-value = 0.15) Results: IOP - Glaucoma Patients Statistical y significant between groups (p-value = 0.004) – All IOPs returned to baseline by week-1 Results: Anterior Chamber Inflammation Summed ocular inflammation score (SOIS) were used to assess degrees of inflammation Not statistically significant between groups: p-value = 0.39
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Results – Macular OCT – Studied Population Foveal thickness between the groups showed no statistical significance (p = 0.82) – Macular OCT – Diabetic Population Foveal thickness within one-standard deviation of the mean between the three groups were not statistically significant (p = 0.35) – Macular OCT – Diabetic with NPDR Macular thickness was not statistically different (p = 0.45) Conclusion – Group I had the smallest IOP flux compared to Control & Group II – All three regimen were efficacious in controlling AC inflammation – All three regimen were efficacious in preventing cystoid macular edema in the non-diabetic and diabetic patients
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Total/FinalEyeSexAge (years)POAG/ GS DMDM with NPDR Control49/41OD = 17 OS = 24 M = 20 F = 21 69.4 ± 11.31093 Group I48/40OD = 24 OS = 16 M = 15 F = 25 70.1 ± 12.48114 Group II40/30OD = 17 OS = 13 M = 12 F = 18 69.8 ± 11.6665 Key: M = male; F = female, POAG = primary open angle glaucoma; GS = glaucoma suspect; DM = diabetes mellitus II; NPDR = non-proliferative diabetic retinopathy
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Intraocular pressure (mmHg)AC Inflammation (SOIS)OCT (µm) Pre1-day1-wk1-mthPre1-day1-wk 1- mth Pre1-wk1-mth Control15.4±3.222.2±8.115.4±3.215.0±3.702.1±0.40.80±0.40200±21204±20201±21 Group I15.3±2.718.2±5.514.9±2.514.2±2.502.2±0.40.79±0.40203±25205±23 Group II15.1±2.721.0±8.314.4±2.714.2±3.002.2±0.50.88±0.40199±25207±23201±24 p-value between groups = 0.150.390.82 p-value within groups = 0.120.430.06 Key: SOIS = summed ocular inflammatory score Table 2: Pre-operative & Post-operative Variable Data Effect – IOPValueF Hypothesis df Error dfSig. Partial Eta Squared Noncent. Parameter Observed Power b Pillai’s Trace Wilk’s Lambda Hotelling’s Trace Roy’s Largest Root 0.089 0.911 0.097 0.089 1.667 1680 a 1.692 3.185 c 6.000 3.000 214.000 212.000 210.000 107.000 0.130 0.127 0.124 0.027 0.045 0.046 0.082 10.003 10.079 10.152 9.555 0.629 0.633 0.636 0.722 a = Exact statistic; b = computed using alpha = 0.05; c = The statistic is an upper bound on F that yields a lower bound on the significance level; d = Design: intercept + group Table 3: Multivariate Tests – Power Analysis for Intraocular Pressure
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Figure 1: Intraocular Pressure for the Studied Population
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Figure 1: Intraocular Pressure for the Glaucoma Population
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Diabetics (Total)Diabetic with NPDR Pre1-wk1-mthPre1-wk1-mth Control196±17 196±16204±17202±17199±6 Group I205±23211±21207±25206±23207±22202±29 Group II195±18203±17195±19199±19205±16203±18 p-value between groups = 0.350.77 p-value within groups = 0.450.85 Key: NPDR = non-proliferative diabetic retinopathy Table 5: OCT Data among Diabetics with and without NPDR EffectValueF Hypothesis df Error df Sig. Partial Eta Squared Noncent. Parameter Observed Power b Pillai’s Trace Wilk’s Lambda Hotelling’s Trace Roy’s Largest Root 0.080 0.920 0.087 0.086 2.243 2.269 a 2.295 4.654 c 4.000 2.000 216.000 214.000 212.000 108.000 0.065 0.063 0.060 0.012 0.040 0.041 0.042 0.079 8.972 9.078 9.180 9.307 0.651 0.657 0.662 0.773 a = Exact statistic; b = computed using alpha = 0.05; c = The statistic is an upper bound on F that yields a lower bound on the significance level; d = Design: intercept + group Table 4: Multivariate Tests – Power Analysis for Macular Edema
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Efficacy among the three regimens in – Resolving anterior chamber inflammation – Preventing the development of macular edema – IOP spikes were significant in the glaucoma population on day-1 Group I – NSAIDs along demonstrated a lowest rise in IOP post-operatively Larger population size & longer post operative evaluation is warranted
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References Moshirfar M, Feiz V, Vitale AT, et al. Endophthalmitis after uncomplicated cataract surgery with the use of fourth-generation fluoroquinolones: a retrospective observational case series. Ophthalmology. 2007;114:686–691. Cho H, Wolf KJ, Wolf EJ. Management of ocular inflammation and pain following cataract surgery: focus on bromfenac ophthalmic solution. Clin Ophthalmol. 2009;3:199-210. Jabs DA, Nussenblatt RB, Rosenbaum JT. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005;140(3):509-516. Hirooka K, Shiraga F, Tanaka S, et al. Risk factors for elevated intraocular pressure after trans-tenon retrobulbar injections of triamcinolone. Jpn J Ophthalmol. 2006;50(3):235-238. Fang EN, Kass MA. Increased intraocular pressure after cataract surgery. Semin Ophthalmol. 1994;9:235-242. Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-889. Affiliations 1.Westfield Eye Center – 2575 Lindell Road, Las Vegas, NV 89146 2.Nevada State College – 1125 Nevada State Drive, Henderson, NV 89002 Contact Hon-Vu Q. Duong, M.D., 2575 Lindell Road, Las Vegas, NV 89146 Email: hon-vu.duong@nsc.nevada.edu
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