Prospective, Randomized, Double-Blind Study Comparing Nepafenac 0.1% (Nevanac™) and
Bromfenac Sodium 0.09% (Xibrom™) in Post-Op Cataract Patients
Hon-Vu Q. Duong, M.D.1,2
Kenneth C. Westfield, M.D., M.B.A.1
Isaac C. Singleton, O.D.1
None of the authors have any financial interests nor was the study supported by any unrestricted grant from government
or non government agencies.
Abstract• Purpose
– To objectively compared two FDA approved NSAIDs in post-operative cataract patients
• Design– Prospective, randomized, double-blind study conducted at
a single center, private practice in Las Vegas, Nevada– Two end points were measured
• Is OCT sensitive in detecting early or subclinical cystoid macular edema
• Incidence of CME between nepafenac 0.1% and bromfenac 0.09%
Abstract
• Methods– IRB approved– Patients were randomized into two groups
• Group #1: bromfenac sodium 0.09% + prednisolone acetate 1% + moxifloxicin hydrochloride 0.5% (N=88)
• Group #2: nepafenac 0.1% + prednisolone acetate 1% + moxifloxicin hydrochloride 0.5% (N=85)
• Pre-operative evaluation and measured values included: best corrected visual acuity (Va), intraocular pressure by applanation (IOP), anterior and posterior segment evaluation, and baseline OCT
• All surgeries were performed by one surgeon (KCW), all post op evaluations were performed by one doctor of optometry (ICS)
AbstractResults• Variables measured were not statistically significant with the p-value > 0.05 at
baseline and on post-op day(s) 1, 7, & 30. • Three patients in each group had clinically significant macular edema and all were
followed with serial OCT3 scans. • Thirteen patients in the nepafenac group and 14 patients in the bromfenac group
were noted to have subclinical macular edema based on OCT findings. • OCT was also sensitive in detecting subclinical macular edema in four patients with
non-proliferative diabetic retinopathy; two patients in each group respectively.
Conclusions • Both NSAIDs have shown to be efficacious with no statistically significant
differences in post-operative cataract care.• OCT3 was more sensitive in detecting early macular edema than clinical
examination.
Demographic
Bromfenac Nepafenac Bromfenac Nepafenac
Total Enrolled 103 102 Comorbidities
Completed 88 85 Diabetic 29 (33%) 30 (35.3%)
Lost to F/U 15 17 ARMD 19 (21.6%) 22 (25.9%)
Average Age 69.39 ± 9.15 68.52 ±9.28 POAG 21 (23.9%) 24 (28.2%)
Age Range 40-85 41-84 GS/OHTN 11 (12.5%) 9 (10.6%)
Sex ERM 2 (2.27%) 2 (2.35%)
Male 38 (43.2%) 49 (57.6%) Other 14 (15.9%) 12 (14.1%)
Female 50 (56.8%) 36 (42.4%)
Eyes
OD 52 (59.1%) 43 (50.6%)
OS 36 (40.9%) 42 (49.4%)
ARMD = age-related macular edemaPOAG = primary open angle glaucomaGS/OHTN = glaucoma suspect/ocular hypertensionERM = epiretinal membrane
Visual Acuity and Mean IOP
Baseline POD #1 POD #7 POD #30
Visual Acuity in Log MAR ± SD
Bromfenac 0.63 ± 0.53 0.5 ± 0.49 0.29 ± 0.34 0.15 ± 0.21
Nepafenac 0.54 ± 0.58 0.55 ± 0.53 0.28 ± 0.22 0.19 ± 0.2
Statistical Value (p < 0.05) p = 0.23 p = 0.38 p = 0.06
Mean IOP in mmHg ± SD
Bromfenac 16.25 ± 3.45 20.57 ± 6.87 14.95 ± 2.84 14.52 ± 2.58
Nepafenac 16.19 ± 3.04 20.84 ± 7.69 16.08 ± 3.53 15.48 ± 2.87
Statistical Value (p < 0.05) p = 0.39 p = 0.23 p = 0.44
POD = post-operative day
Foveal & Central Foveal ThicknessTotal Patient FT Baseline FT 1-week CFT Baseline CFT 1-week
Bromfenac (N = 88) 206.65 ± 16.38 220.58 ± 22.21 174.44 ± 8.99 184.86 ± 12.28
Nepafenac (N = 85) 207.84 ± 12.88 222.84 ± 22.03 176.68 ± 11.31 187.79 ± 15.29
p < 0.05 p = 0.30 p = 0.25 p = 0.07 p = 0.08
Diabetic FT Baseline FT 1-week CFT Baseline CFT 1-week
Bromfenac (N = 29) 218.03 ± 20.18 226.86 ± 22.02 175.41 ± 7.89 182.38 ± 10.05
Nepafenac (N = 30) 214.27 ± 12.35 225.30 ± 16.03 178.57 ± 13.49 186.70 ± 13.60
p < 0.05 p = 0.19 p = 0.38 p = 0.14 p = 0.085
FT = foveal thickness in micrometer: the mean thickness within the central 1000 micron diameter area of the fovea.4
CFT = central foveal thickness in micrometer: the mean thickness measured at the point of intersection of the six radial scans by OCT.4
Foveal & Central Foveal Thickness in Diabetics by OCT
182.38
175.41
226.86
218.03
186.70
178.57
225.30
214.27
0.00 50.00 100.00 150.00 200.00 250.00
CFT @ 1 week
CFT Baseline
FT @ 1 week
FT Baseline
Macular Thickness in micrometers
Xibrom Nevanac
Foveal & Central Foveal Thickness by OCT - Study Populatin
184.86
174.44
220.58
206.65
187.79
176.68
222.84
207.84
0 50 100 150 200 250
CFT @ 1 week
CFT Baseline
FT @ 1 week
FT Baseline
Macular Thickness in micrometers
Xibrom Nevanac
Incidence of Cystoid Macular EdemaIncidence of Cystoid Macular Edema
14
3
2
0
13
3
2
0
0 2 4 6 8 10 12 14 16
CME Detected on OCT
Clinical CME
Diabetics with CME by OCT
Diabectics with Clinical CME
Met
ho
d o
f D
iag
no
sis
Number of Patients
Xibrom Nevanac
CME by OCT FT Baseline FT 1-week CFT Baseline CFT 1-week
Bromfenac (N = 14) 215.15 ± 15.42 225.15 ± 20.01 177.46 ± 4.86 184.08 ± 7.54
Nepafenac N = 13) 207.08 ± 10.32 220.92 ± 17.44 183.25 ± 14.47 193.92 ± 15.48
p-value (p < 0.05) P = 0.68 P = 0.29 P = 0.11 P = 0.032FT = foveal thickness; CFT = central foveal thicknessCME = cystoid macular edemaOCT = optical coherency tomography
Discussion/Conclusion
• Cystoid macular edema (CME) was determined both clinically as well as by OCT3.
• In our study, CME by OCT was defined: foveal and central foveal thickness 2 SD outside the mean
• In our study, OCT3 was highly sensitive in diagnosing early subclinical CME.– Incidence of CME (clinically) was not statistically significant
between the two topical NSAIDs.– Incidence of CME by OCT based on CFT was statistically
significant. However, OCT base FT was not statistically significant.
– Incidence of CME in diabetics (clinically and by OCT) was not statistically significant between the two topical NSAIDs.
Discussion/Conclusion
• Both topical NSAIDs performed reliably well throughout the study period.– High degree of compliances during the study
period based on patient reporting• No statistical significant differences in all the
parameters measured between bromfenac and nepafenac.
• Both topical NSAIDs are efficacious their purported pharmacological properties.
References
1. Almeida D., Johnson D., Hollands H., et al. Effect of prophylactic nonsteroidal antiinflammatory drugs on cystoid macular edema assessed using optical coherence tomography quantification of total macular volume after cataract surgery. J Cataract Refract Surg , 2008;34:64-69.
2. Brown J., Solomon S., Bressler S., et al. Detection of Diabetic Foveal Edema. Arch Ophthalmol. 2004;122:330-335.
3. Polito A., Del Borrello M., Isola M., et al., Repeatability and Reproducibility of Fast Macular Thickness Mapping With Stratus Optical Coherence Tomography. Arch Ophthalmol. 2005;123:1330-1337.
4. Chan A., Duker J., Ko T., et al., Normal Macular Thickness Measurements in Healthy Eyes Using Stratus Coherence Tomography. Arch Ophthalmol. 2006;124:194-198.
5. Pires I., Bernardes R., Lobo C., et al., Retinal Thickness in Eyes With Mild Nonproliferative Retinopathy in Patients With Type 2 Diabetes Mellitus. – Comparison of Measurements Obtained by Retinal Thickness Analysis and Optical Coherence Tomography, Arch Ophthalmology 2002;120:1301-1306.
6. Thomson, Physicians’ Desk Reference – 2008, www.pdr.net.7. Ista Laboratories, Package Insert, Xibrom.
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: [email protected]
