None of the authors have any financial interests nor was the study supported by any unrestricted grant from government or non government agencies.
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
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
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
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
Total/FinalEyeSexAge (years)POAG/ GS DMDM with NPDR Control49/41OD = 17 OS = 24 M = 20 F = ± Group I48/40OD = 24 OS = 16 M = 15 F = ± Group II40/30OD = 17 OS = 13 M = 12 F = ± Key: M = male; F = female, POAG = primary open angle glaucoma; GS = glaucoma suspect; DM = diabetes mellitus II; NPDR = non-proliferative diabetic retinopathy
Intraocular pressure (mmHg)AC Inflammation (SOIS)OCT (µm) Pre1-day1-wk1-mthPre1-day1-wk 1- mth Pre1-wk1-mth Control15.4± ± ± ± ± ± ±21204±20201±21 Group I15.3± ± ± ± ± ± ±25205±23 Group II15.1± ± ± ± ± ± ±25207±23201±24 p-value between groups = p-value within groups = 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 a c 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
Figure 1: Intraocular Pressure for the Studied Population
Figure 1: Intraocular Pressure for the Glaucoma Population
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 = p-value within groups = 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 a c 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
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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