Alternative Pharmaceutical Management for Post Cataract Extraction: A Prospective, Randomized Study

Alternative Pharmaceutical Management for Post Cataract Extraction: A Prospective, Randomized StudyHon-Vu Q. Duong,1,2 M.D.Kenneth C. Westfield,1 M.D., M.B.A.Isaac C. Singleton,1 O.D. M.P.A. F.A.A.O.None of the authors have any financial interests nor was the study supported by any unrestricted grant from government or non government agencies.AbstractPurposeTo objectively compare the efficacy of three pharmacological regimen post cataract extractionDesignIRB approved, prospective, randomized, single-blind study conducted at a single center, private, teaching practice in Las Vegas, Nevada. Three variables (end points) were measuredDegree of intraocular spikeDegree anterior chamber inflammationIncidence of cystoid macular edemaAbstractMethodsPatients were randomized into three groupsControl: 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 OCTPost-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 monthAll surgeries were performed by one surgeon. All IOP measurements & OCT scans were performed by one certified techAbstractResults: Intraocular Pressure Studied PopulationGreatest IOP flux occurred on post-op day-1Control & 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 PatientsStatistical y significant between groups (p-value = 0.004) All IOPs returned to baseline by week-1Results: Anterior Chamber InflammationSummed ocular inflammation score (SOIS) were used to assess degrees of inflammationNot statistically significant between groups: p-value = 0.39

AbstractResultsMacular OCT Studied PopulationFoveal thickness between the groups showed no statistical significance (p = 0.82)Macular OCT Diabetic PopulationFoveal thickness within one-standard deviation of the mean between the three groups were not statistically significant (p = 0.35)Macular OCT Diabetic with NPDRMacular thickness was not statistically different (p = 0.45)ConclusionGroup I had the smallest IOP flux compared to Control & Group IIAll three regimen were efficacious in controlling AC inflammationAll three regimen were efficacious in preventing cystoid macular edema in the non-diabetic and diabetic patientsTable 1: DemographicTotal/FinalEyeSexAge (years)POAG/GSDMDM with NPDRControl49/41OD = 17OS = 24M = 20F = 2169.4 11.31093Group I48/40OD = 24OS = 16M = 15F = 2570.1 12.48114Group II40/30OD = 17OS = 13M = 12F = 1869.8 11.6665Key: M = male; F = female, POAG = primary open angle glaucoma; GS = glaucoma suspect; DM = diabetes mellitus II; NPDR = non-proliferative diabetic retinopathyDataIntraocular pressure (mmHg)AC Inflammation (SOIS)OCT (m)Pre1-day1-wk1-mthPre1-day1-wk1-mthPre1-wk1-mthControl15.43.222.28.115.43.215.03.702.10.40.800.40200212042020121Group I15.32.718.25.514.92.514.22.502.20.40.790.40203252052320523Group II15.12.721.08.314.42.714.23.002.20.50.880.40199252072320124p-value between groups = 0.150.390.82p-value within groups = 0.120.430.06Key: SOIS = summed ocular inflammatory scoreTable 2: Pre-operative & Post-operative Variable DataEffect IOPValueFHypothesis dfError dfSig.Partial Eta SquaredNoncent. ParameterObserved PowerbPillais TraceWilks LambdaHotellings TraceRoys Largest Root0.0890.9110.0970.0891.6671680a1.6923.185c6.0006.0006.0003.000214.000212.000210.000107.0000.1300.1270.1240.0270.0450.0450.0460.08210.00310.07910.1529.5550.6290.6330.6360.722a = 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 + groupTable 3: Multivariate Tests Power Analysis for Intraocular PressureFigure 1: Intraocular Pressure for the Studied PopulationFigure 1: Intraocular Pressure for the Glaucoma PopulationDataDiabetics (Total)Diabetic with NPDRPre1-wk1-mthPre1-wk1-mthControl196171961719616 20417202171996Group I205232112120725206232072220229Group II195182031719519199192051620318p-value between groups = 0.350.77p-value within groups = 0.450.85Key: NPDR = non-proliferative diabetic retinopathyTable 5: OCT Data among Diabetics with and without NPDREffect ValueFHypothesis dfError dfSig.Partial Eta SquaredNoncent. ParameterObserved PowerbPillais TraceWilks LambdaHotellings TraceRoys Largest Root0.0800.9200.0870.0862.2432.269a2.2954.654c4.0004.0004.0002.000216.000214.000212.000108.0000.0650.0630.0600.0120.0400.0410.0420.0798.9729.0789.1809.3070.6510.6570.6620.773a = 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 + groupTable 4: Multivariate Tests Power Analysis for Macular EdemaDiscussion/ConclusionEfficacy among the three regimens in Resolving anterior chamber inflammationPreventing the development of macular edemaIOP spikes were significant in the glaucoma population on day-1 Group I NSAIDs along demonstrated a lowest rise in IOP post-operativelyLarger population size & longer post operative evaluation is warrantedReferencesMoshirfar 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;114:686691. 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.AffiliationsWestfield Eye Center 2575 Lindell Road, Las Vegas, NV 89146Nevada State College 1125 Nevada State Drive, Henderson, NV 89002ContactHon-Vu Q. Duong, M.D., 2575 Lindell Road, Las Vegas, NV 89146Email: hon-vu.duong@nsc.nevada.edu