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

1. Alternative Pharmaceutical Management for Post Cataract Extraction: A Prospective, Randomized Study Hon-Vu Q. Duong,1,2 M.D. Kenneth C. Westfield,1M.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.

2. Abstract • 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

3. Abstract • 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

4. Abstract • 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

5. Abstract • 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

6. Table 1: Demographic Key: M = male; F = female, POAG = primary open angle glaucoma; GS = glaucoma suspect; DM = diabetes mellitus II; NPDR = non-proliferative diabetic retinopathy

7. Data • Table 2: Pre-operative & Post-operative Variable Data Key: SOIS = summed ocular inflammatory score • Table 3: Multivariate Tests – Power Analysis for Intraocular Pressure 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

8. Figure 1: Intraocular Pressure for the Studied Population

9. Figure 1: Intraocular Pressure for the Glaucoma Population

10. Data • Table 5: OCT Data among Diabetics with and without NPDR Key: NPDR = non-proliferative diabetic retinopathy • Table 4: Multivariate Tests – Power Analysis for Macular Edema 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

11. Discussion/Conclusion • 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

12. References • MoshirfarM, 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. ClinOphthalmol. 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. • HirookaK, Shiraga F, Tanaka S, et al. Risk factors for elevated intraocular pressure after trans-tenonretrobulbar injections of triamcinolone. Jpn J Ophthalmol. 2006;50(3):235-238. • Fang EN, Kass MA. Increased intraocular pressure after cataract surgery. SeminOphthalmol. 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 • Westfield Eye Center – 2575 Lindell Road, Las Vegas, NV 89146 • 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