Journal of Xi’an Shiyou University, Natural Science Edition ISSN: 1673-064X

THE CLINICAL IMPACT OF NEPAFENAC 0.3% OPHTHALMIC SUSPENSION IN

POST-OPERATIVE CATARACT DIABETIC PATIENTS

Rabia Bushra Ehsan1, Shakila Abbas1, Idrees Khan2, Fariah Ata1, Fareena Tehreem1,
Aneela Farid1, Zikra Shifa3,

1:Department of Optometry, The University of Faisalabad1

2: Department of Eastern Medicine, Superior University2
3: Rashid Latif Medical Complex

ABSTRACT
Background: Diabetes mellitus is a group of metabolic disorders which is followed by chronic
hyperglycemia.
Aim: To assess the impact of 0.3% nepafenac ophthalmic suspension on macular thickness in
mild and moderate NPDR following cataract surgery.
Methodology: This quasi-experimental study used non-probability purposive sampling from
September 22 to May 23. Sixty patients with type 2 diabetes of 40-65 years of age, good
glycemic control and mature cataracts were to undergone phacoemulsification were included.
Patients with complicated cataract surgery or using topical or systemic NSAIDs and steroids and
proliferative or severe NPDR were excluded. Diabetic cataract patients split into two groups of
with and without taking nepafenac. Each group of 30 patients is divided into two subgroups of
15 patients in each with mild and moderate NPDR. All patients were examined for macular
thickness by OCT before, one week and one month following cataract surgery. Data was
analyzed by repeated measure ANOVA.
Results: Mild NPDR patients with taking nepafenac had mean macular thicknesses of 228µm,
224µm and 216µm while patients without taking nepafenac had mean macular thicknesses of
230µm, 244µm and 247µm preoperatively, one week, and one month after cataract surgery.
Moderate NPDR patients with taking nepafenac had mean macular thicknesses of 260µm,
253µm and 245µm while patients without taking nepafenac had mean macular thicknesses of
258µm, 274µm and 282µm preoperatively, one week, and one month after cataract surgery. All
groups had p < 0.05 (.000).

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Conclusion: 0.3% nepafenac ophthalmic suspension is effective in reducing macular thickness

in diabetic patients following cataract surgery with mild and moderate NPDR.
Keywords: Cataract Extraction, Non-steroidal anti-inflammatory drug, Macular edema,
Retinopathy
INTRODUCTION
Diabetes mellitus is a term used to describe a collection of metabolic diseases that cause a long-
term insulin resistance caused by insufficient insulin secretion, decreased responsiveness to
insulin, or a combination of the two (1). The most common microvascular complication of
diabetes is diabetic retinopathy (2). Vision loss from diabetic retinopathy may be one of the most
distressing microvascular problems for those who are affected. The main risk factors for diabetic
retinopathy are age, the duration of diabetes, poor glycemic control and other factors like
obesity, nephropathy and dyslipidemia. DR is a rising global concern. DR now affects nearly 100
million people throughout the world and is anticipated to become a growing health issue,
indicating that diabetes related vision loss and blindness increased 64% and 27%, respectively,
between 1990 and 2010 (3). The diagnosis of diabetic retinopathy is made on the basis of clinical
investigation of vascular anomalies in the retina (4).
Non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) are
two clinically recognized stages of DR. NPDR is first stage of DR, which is characterized by
capillary blockage and increased vascular permeability in the vasculature of retina. The
microvascular characteristics features of NPDR include intraretinal haemorrhages,
microaneurysms, abnormalities in venous calibre, intraretinal microvascular abnormalities
formation, lipid exudates from the damaged vessels, retinal neovascularization and cotton-wool
spots (5). The patients of diabetic retinopathy are asymptomatic initially; detailed fundus
photography can detect minor retinal changes such as microaneurysms, haemorrhages, and hard
exudates (4). NPDR is further categorized into mild, moderate, and severe categories, depending
on whether or not diabetic macular edema develops (6).

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Diabetic
Retinopathy

Proliferative
Non-Proliferative
Diabetic
Diabetic Retinopathy
Retinopathy

Very
Mild Moderate Severe
Severe PDR
NPDR NPDR NPDR
NPDR

Microaneurysms Microaneurysms The rule 4-2-1 New Vessels on

2 or more of
Retinal Severe haemorrhage the criteria for the disc(NVD)
Haemorrhages in all 4 quadrant severe NPDR New Vessels
Exudates Significant venous Elsewhere(NVE)
Cotton wool spots beading in 2 or
more quadrant
Venous Beading
may be present no Moderate IRMA in
more than 1 one or more
quadrant quadrant

Figure 1.1: Classification of Diabetic Retinopathy.

Cataract is a main cause of vision loss in diabetic patients due to the fact that diabetic patients
have a higher risk of developing cataracts and a faster rate of progression of existing cataracts
(7). People diagnosed with diabetes under the age of 65 have a three- to fourfold increased risk
of developing cataracts. Cataracts are twice as common in people over the age of 65 (8). There is
evidence to suggest that people who have diabetes mellitus are at an increased risk of developing
cataracts (9).
Following cataract surgery, inflammation appears to be a major cause of pseudophakic cystoid
macular edema, according to the majority of researchers. The arachidonic acid is released from
uveal tissue which may result in the production of inflammatory mediator leukotrienes by the
lipoxygenase pathway or production of prostaglandins (PGs) via the cyclooxygenase (COX)
pathway, according to the theory. All of these mediators of inflammation then penetrate
posteriorly into the vitreous, thereby destroying the barrier that separates the blood and the
retina. This disruption causes an increase in perifoveal capillary permeability and accumulation
of fluid in the retina. Despite the retina's extensive formation and distribution of inflammatory
mediators such as cytokines, it is not known why fluid collects in the macula as a result of
perifoveal capillary leakage (10).

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Optical coherence tomography, also known as OCT, is a reliable method for diagnosing
pseudophakic CME because it can detect morphologic changes at an early stage and shows
foveal cysts as a symptom of the disease. Because of the accumulation of intraretinal fluid in the
outer plexiform layer and the regulation of the layout of cystoid cavities by Muller fibres, the
typical appearance of an OCT scan is produced, and the thickness of the macula is also increased
(11). Changes in macula are more likely to occur in diabetic patients, particularly those who have
a history of retinopathies, following cataract surgery than they are in people who do not have
diabetes (12).
Corticosteroids are used as a treatment for PCME because they inhibit the synthesis of
prostaglandins and leukotriene. Corticosteroids inhibit phospholipase A2 in the arachidonic acid
cascade, which results in decreased production of prostaglandin (PG). In addition to having anti-
inflammatory effects, corticosteroids prevent the migration of macrophages and neutrophils,
lessen the permeability of capillaries, and increase the constriction of blood vessels and decrease
vasodilation (13). Corticosteroids are effective at reducing inflammation following surgery, but
they have little effect on reduction of PCME and may result in rise of intraocular pressure (14).
Nepafenac is approved by FDA for use to treat postoperative inflammation brought on by
cataract surgery and to reduce the risk of development of postoperative ME in diabetic patients.
Nepafenac is also used to treat diabetic patients who have already experienced postoperative ME.
There are two different formulations of the Nepafenac solution available: one with a dosing
frequency of 0.1% three times per day, and the other with a dosing frequency of 0.3% once per
day for improved compliance (9).
Nepafenac is prescribed to diabetic patients in order to reduce the likelihood that they will
experience postoperative macular edema and treat inflammation brought on by cataract surgery
(15). The corneal epithelium is penetrated well by nepafenac. Nepafenac is a drug that quickly
perforates the cornea, and it is deaminated by hydrolases within the ocular structures such as the
ciliary body epithelium, choroid, and retina to create the active metabolite, which is amfenac.
Both COX-1 and COX-2 are blocked by amfenac's action, which results in a highly strong
reduction in prostaglandin production (16). In comparison to other non-steroidal anti-
inflammatory drugs, after topical treatment, it is anticipated that nepafenac will have good
corneal penetration to intraocular tissues, and will therefore reach the posterior region of the eye
(17). Nepafenac is the medication of choice of many eye doctors who treat diabetic patients (18).

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1.2: OBJECTIVES
• To assess the macular thickness in post-operative diabetic patients with mild and moderate
non-proliferative diabetic retinopathy.
• To assess the impact of 0.3% Nepafenac ophthalmic suspension on macular thickness in
post-operative diabetic patients with mild and moderate non-proliferative diabetic
retinopathy.
MATERIALS AND METHODS
Study design
Quasi experimental study design was used.
Place of study
The study was conducted at Arif Memorial Teaching Hospital.
Duration of study
The duration of study was from September 2022 to May 2023.
Sample size
The sample size was calculated 60 for study by using Raosoft formula with confidence interval
of 95% and margin of error 5%. The sample size of sixty was divided into two groups. One
group of thirty patients not taking nepafenac and another group of thirty patients taking
nepafenac was further divided into two groups of fifteen each either having mild or moderate
type of non-proliferative diabetic retinopathy.
Sampling technique
The data was conducted by the Nonprobability Purposive Sampling technique.
Inclusion criteria
• Age 40-65 years
• Both genders were included
• Patient with Type 2 diabetes mellitus
• Good Diabetic control
• Type 2 diabetes mellitus with mild non-proliferative diabetic retinopathy
• Type 2 diabetes mellitus with moderate non-proliferative diabetic retinopathy
• Mature cataracts and were to undergo phacoemulsification with implantation of the
intraocular lens.

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• All patients underwent phacoemulsification with posterior chamber lens implantation.

• Patient taking Nepafenac 0.3% ophthalmic suspension
Exclusion criteria
• Proliferative and severe stage of non-proliferative diabetic retinopathy
• Patients who had macular cysts, epiretinal membranes, and macular traction.
• Macular thickness greater than 300 µm were excluded.
• Patients with surgically cut corneal nerves, dry eye syndrome, penetrating grafts, pre-
existing uveitis, glaucoma, or any significant pathology of the posterior segment.
• Diabetes mellitus patient with uncontrolled diabetes, cardiac problems, and rheumatoid
arthritis
• Any patients who had complicated cataract surgery e.g., vitreous loss significant corneal
edema, retained cortical material, rupture of the posterior capsule, or an intraocular lens
not placed in the capsular bag.
• Patient using medications such as topical or systemic nonsteroidal anti-inflammatory
drugs and steroids
Data Collection Instruments These instruments were used in this research study
• Slit Lamp (Carl Zeiss Meditec AG 07740 Jena)
• Optical Coherence Tomography (Niddek RS 3000)

Research Tools This research was carried out by self-structured Proforma.

Data Collection Methods
A total of 60 diabetic cataract patients including both genders, aged 40 to 65, were selected at
Arif Memorial Hospital and Ittefaq Hospital Lahore. This Quasi experimental study design was
conducted from September 22 to May 2023. The study included participants who met the
inclusion criteria and provided their informed consent. After taking history the diabetic cataract
patients were divided into two groups. One group of thirty patients not taking nepafenac and
another group of thirty patients taking nepafenac was further divided into two groups of fifteen
each for those having mild and moderate type of non-proliferative diabetic retinopathy. After
taking informed consent the data was collected by using a slit lamp and patients was evaluated
for cataract surgery. All patients were examined for macular thickness by OCT before, after, and
after one month of surgery.
Data Analysis Method
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Data analysis was done on the statistical package for the social sciences (SPSS) by applying
repeated measure ANOVA.
Ethical Consideration
Each participant was instructed on the entire procedure and instructed on how to apply topical
0.3% Nepafenac drops. They were assured that any information they provided would be held in
strict confidence and used solely for research purposes. Both verbal and written consent will be
obtained from the patients briefing them sufficiently on the study's objectives and design,
assuming appropriate time to examine all possibilities, ensuring that the included subjects grasp
this information, volunteering subject matter and continuing to provide information, exchange
information, and ask questions.
RESULTS
This study included sixty diabetic patients having mild and moderate non-proliferative
diabetic retinopathy above forty to sixty-five years of age. Patients were divided into two
groups. Thirty patients taking nepafenac along with conventional treatment after cataract
surgery were kept in group 1. Thirty patients taking conventional treatment only were kept
in group 2. Macular thickness was assessed in both groups. Results were analyzed by
using repeated measure ANOVA.
4.1: Description of age of diabetic retinopathy patients taking nepafenac and without
taking nepafenac
A total of sixty patients were selected of the age above than forty year and divided into
two groups, one group of patients taking nepafenac and other without taking nepafenac.
Out of this age range, the maximum and minimum age with which patients presented in
group of patients taking nepafenac and other without taking nepafenac was 65 years and
45 years, 49 years and 65 years respectively. The mean value and standard deviation of
the age were found to be 53.90 ± 5.71 in patients taking nepafenac and 56.70 ± 4.77 in
patients without taking nepafenac as described in table 4.1.

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Table 4.1: Age of patients of diabetic retinopathy with and without taking nepafenac.

Minimum Maximum Mean Std. Deviation

Age of the 45.00 65.00 53.9000 5.71357
Patients taking
nepafenac
Age of the 49.00 65.00 56.7000 4.77890
Patients
without taking
nepafenac

4.2: Distribution of gender of diabetic retinopathy patients taking nepafenac

Out of the total sixty subjects for this study, one group of patients taking nepafenac and other
without taking nepafenac. The percentage of gender distribution in both groups with and without
taking nepafenac was 26.7% (N=16), 28.3% (N=17) were males and 23.3% (N=14), 21.7%
(N=13) were females respectively as described in the table 4.2 and figure 4.1.
Table 4.2: Gender of diabetic retinopathy patients with and without taking nepafenac.
Gender of the patients
Gender Frequency Percent Valid Cumulative
percent
percent
Gender of the
Male 16 26.7 53.3 53.3
Patients
Female 14 23.3 46.7 100.0
taking
nepafenac
Gender of the
Male 17 28.3 56.7 56.7
Patients
Female 13 21.7 43.3 100.0
not taking
nepafenac
Total 60 100.0 100.0

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26.7% 28.3%
30 23.3% 21.7%
25
20
15
10
5
0
Male Female
Patients taking nepafenac Patients not taking nepafenac

Figure 4.1: Gender of the patients with and without taking Nepafenac.

After applying the normality test on the data, p value of Shapiro-Wilk test is greater than
0.05. P value indicates that data was normal and parametric test were applied for analysis.
Repeated measure ANOVA were used for analysis of the data.

4.3: Assessment of macular thickness in mild non-proliferative diabetic retinopathy

patients taking nepafenac
Out of sixty patients, fifteen patients were taking nepafenac with mild non-proliferative
diabetic retinopathy following cataract surgery. The mean value and standard deviation of
macular thickness recorded pre-operatively, one week, one month following cataract
surgery were 228.20 ± 7.022, 224.40 ± 9.78, 216.22 ± 9.059 respectively. The p value was
< 0.05 (p= 0.000) which shows that result of this study was significant even within the
subjects. According to the findings there was a significant difference present in the
macular thickness mean values recorded at different time intervals as described in table
4.3, 4.4 and figure 4.2.

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Table 4.3: Central Macular thickness in mild non-proliferative diabetic retinopathy

using nepafenac.
Mean St. Deviation N
Central macular 228.20 7.02 15
thickness before
using nepafenac
in mild NPDR

Central macular 224.40 9.78 15

thickness one
week after using
nepafenac in
mild NPDR

Central macular 216.22 9.05 15

thickness one
month after
using nepafenac
in mild NPDR

230 228.2µm
228
224.4µm
Macular Thickness in µm

226
224
222
220
218 216.22µm
216
214
212
210

Figure 4.2: Central Macular thickness in mild non-proliferative diabetic retinopathy

using nepafenac.

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Table 4.4: Repeated measures ANOVA test.

Type III df Mean F Sig
Sum of Square
Squares
Group 1 Sphericity 1114.97 2 557.48 24.10 0.000
Assummed

Greenhouse- 1114.97 1.624 686.49 24.10 0.000

Geisser

Pairwise comparison for mild non proliferative diabetic retinopathy in patients taking nepafenac
shows the relationship of pre-operative data(1) with follow up 1(2) and follow up 2(3),
comparison of follow up 1(2) with preoperative data(1) and follow up 2(3) and comparison of
follow up 2(3) with preoperative data(1) and follow up 1(2). The factor 1 represents the Pairwise
comparison for mild non proliferative diabetic retinopathy in patients taking nepafenac. This
Pairwise comparison shows relationship between these follow ups for which the mean difference
and standard error as mentioned in below table. P value was < 0.05 (p= 0.000) which shows that
result of the study was statistically significant.
Table 4.5: Pairwise comparison.

Factor 1 (J) Factor 1 Mean Std. Error Sig

difference (I-J)

1 2 3.800 1.878 0.188

3 11.933 2.022 0.000

2 1 -3.800 1.878 0.188

3 8.133 1.279
0.000
3 1 -11.933 2.022 0.000
2 -8.133 1.279 0.000

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4.4: Assessment of Macular thickness in moderate non-proliferative diabetic retinopathy

patients taking nepafenac
Out of sixty patients, fifteen patients were taking nepafenac with moderate non-proliferative
diabetic retinopathy following cataract surgery. The mean value and standard deviation of
macular thickness recorded pre-operatively, one week, one month following cataract surgery
were 260.33 ± 13.82, 253.33 ± 14.06, 245.66 ± 14.93 respectively. The p value was < 0.05
(p= 0.000) which shows that result of this study was significant even within the subjects.
According to the findings there was a significant difference present in the macular thickness
mean values recorded at different time intervals as described in table 4.6, 4.7 and figure 4.3.
Table 4.6: Central Macular thickness in moderate non-proliferative diabetic
retinopathy using nepafenac.
Mean St. Deviation N
Central macular 260.33 13.82 15
thickness before
using nepafenac
in moderate
NPDR

Central macular 253.33 14.06 15

thickness one
week after using
nepafenac in
moderate NPDR

Central macular 245.66 14.93 15

thickness one
month after
using nepafenac
in moderate
NPDR

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265
Central macular thickness in µm 260.33µm
260
255 253.33µm

250
245.66µm
245
240
235

Figure 4.3: Central Macular thickness in moderate non-proliferative diabetic

retinopathy using nepafenac.
Table 4.7: Repeated measures ANOVA test.
Type III df Mean F Sig
Sum of Square
Squares

Group 1 Sphericity 1614.444 2 807.222 23.555 0.000

Assummed

Greenhouse 1614.444 1.540 1048.348 23.555 0.000

-Geisser

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Pairwise comparison for moderate non proliferative diabetic retinopathy in patients taking
nepafenac shows the relationship of pre-operative data(1) with follow up 1(2) and follow up
2(3), comparison of follow up 1(2) with preoperative data(1) and follow up 2(3) and comparison
of follow up 2(3) with preoperative data(1) and follow up 1(2). The factor 1 represents the
Pairwise comparison for moderate non proliferative diabetic retinopathy in patients taking
nepafenac. This Pairwise comparison shows relationship between these follow ups for which the
mean difference and standard error as mentioned in below table. P value was < 0.05 (p= 0.000)
which shows that result of the study was statistically significant.
Table 4.8: Pairwise comparison.

Factor 1 (J) Factor 1 Mean Std. Error Sig

difference (I-J)

1 2 7.000 2.282 0.025

3 14.667 2.518 0.000

2 1 -7.000 2.282 0.025

3 7.667 1.467 0.000

3 1 -14.667 2.518 0.000

2 -7.667 1.469 0.000

4.5: Assessment of Macular thickness in mild non-proliferative diabetic retinopathy

patients without taking Nepafenac
Out of sixty patients, fifteen patients were not taking nepafenac with mild non-proliferative
diabetic retinopathy following cataract surgery. The mean value and standard deviation of
macular thickness recorded pre-operatively, one week, one month following cataract surgery
were 230.26 ± 7.23, 244.80 ± 12.55, 247.66 ± 11.73 respectively. The p value was < 0.05 (p=
0.000) which shows that result of this study was significant even within the subjects.
According to the findings there was a significant difference present in the macular thickness
mean values recorded at different time intervals as described in table 4.9, 4.10 and figure 4.4.

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Table 4.9: Central Macular thickness in mild non-proliferative diabetic retinopathy

without taking nepafenac.
Mean St. Deviation N

Pre-operative 230.26 7.23 15

Central macular
thickness
without using
nepafenac in
mild NPDR

Central macular 244.80 12.55 15

thickness after
one week
without using
nepafenac in
mild NPDR

Central macular 247.66 11.73 15

thickness after
one month
without using
nepafenac in
mild NPDR

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250 247.6µm

Central macular thickness in µm

244.8µm
245

240

235 230.2µm
230

225

220

Figure 4.4: Central macular thickness in mild non-proliferative diabetic retinopathy

without using nepafenac.
Table 4.10: Repeated measures ANOVA test.
Type III df Mean F Sig
Sum of Square
Squares

Group 2 Sphericity 2610.978 2 1305.489 61.022 0.000

Assummed

Greenhouse 2610.978 1.630 1601.618 61.022 0.000

-Geisser

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Pairwise comparison for mild non proliferative diabetic retinopathy in patients without taking
nepafenac shows the relationship pre-operative data(1) with follow up 1(2) and follow up 2(3),
comparison of follow up 1(2) with preoperative data(1) and follow up 2(3) and comparison of
follow up 2(3) with preoperative data(1) and follow up 1(2). The factor 1 represents the Pairwise
comparison for mild non proliferative diabetic retinopathy in patients without taking nepafenac.
This Pairwise comparison shows relationship between these follow ups for which the mean
difference and standard error as mentioned in below table. P value was < 0.05 (p= 0.000) which
shows that result of the study was statistically significant.
Table 4.11: Pairwise comparison.

Factor 1 (J) Factor 1 Mean Std. Error Sig

difference (I-J)

1 2 -14.533 1.990 0.000

3 -17.400 1.726 0.000

2 1 14.533 1.990 0.000

3 -2.867 1.272 0.122

3 1 0.000
17.400 1.726
2 0.122
2.867 1.272

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4.6: Assessment of Macular thickness in moderate non-proliferative diabetic

retinopathy patients without taking Nepafenac
Out of sixty patients, fifteen patients were not taking nepafenac with moderate non-
proliferative diabetic retinopathy following cataract surgery. The mean value and standard
deviation of macular thickness recorded pre-operatively, one week, one month following
cataract surgery were 258.06 ± 13.88, as 274.00 ± 14.25 and 282.06 ± 17.92 respectively. The
p value was < 0.05 (p= 0.000) which shows that result of this study was significant even within
the subjects. According to the findings there was a significant difference present in the macular
thickness mean values recorded at different time intervals as described in table 4.12, 4.13 and
figure 4.5.
Table 4.12: Central Macular thickness in moderate non-proliferative diabetic retinopathy
without taking nepafenac.
Mean St. Deviation N

Pre-operative 258.06 13.88 15

Central macular
thickness
without using
nepafenac in
moderate NPDR

Central macular 274.00 14.25 15

thickness after
one week
without using
nepafenac in
moderate NPDR

Central macular 282.06 17.92 15

thickness after
one month
without using
nepafenac in
moderate NPDR

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285 282.06µm
Central macular thickness in µm
280
275 274.00µm
270
265
258.06µm
260
255
250
245

Figure 4.5: Central macular thickness in moderate non-proliferative diabetic

retinopathy without using nepafenac.
Table 4.13: Repeated measures ANOVA test.
Type III df Mean F Sig
Sum of Square
Squares

Group 2 Sphericity 2610.978 2 1305.489 61.022 0.000

Assummed

Greenhouse 2610.978 1.630 1601.618 61.022 0.000

-Geisser

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Pairwise comparison for moderate non proliferative diabetic retinopathy in patients without
taking nepafenac shows the relationship pre-operative data(1) with follow up 1(2) and follow up
2(3), comparison of follow up 1(2) with preoperative data(1) and follow up 2(3) and comparison
of follow up 2(3) with preoperative data(1) and follow up 1(2). The factor 1 represents the
Pairwise comparison for moderate non proliferative diabetic retinopathy in patients without
taking nepafenac. This Pairwise comparison shows relationship between these follow ups for
which the mean difference and standard error as mentioned in below table. P value was < 0.05
(p= 0.000) which shows that result of the study was statistically significant.
Table 4.14: Pairwise comparison.

Factor 1 (J) Factor 1 Mean Std. Error Sig

difference (I-J)

1 2 -15.933 3.002 0.000

3 -24.000 3.381 0.000

2 1 15.933 3.002 0.000

3 -8.067 2.666 0.027

3 1 0.000
24.000 3.381
2 0.027
8.067 2.666

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Journal of Xi’an Shiyou University, Natural Science Edition ISSN: 1673-064X

CHAPTER 5
DISCUSSION
The main aim of the study was to find the clinical impact of nepafenac 0.3% ophthalmic
suspension in diabetic patients with mild or moderate non- proliferative diabetic retinopathy
following cataract surgery.
A study conducted by Kwon et al in 2011 to assess the changes of macular thickness by OCT
after cataract surgery. The change in macular thickness was evaluated before cataract
surgery, one week, one to two months and after 6 months after cataract surgery. Macular
edema developed in 19 eyes (18%) of the diabetic group, with 63% developing one month
after surgery. Thirteen (68%) of the 19 eyes with macular edema had resolved by 6 months
after surgery without treatment. It was concluded that there was significant increase in
macular thickness following cataract surgery after one month (19). In present study, the mean
macular thickness pre-operatively, after one week and one month was 230.26 um + 7.23 SD,
244.80 um + 12.55 SD and 247.66 um + 11.73 SD respectively in patients not taking
nepafenac in mild non-proliferative diabetic retinopathy. The P value was < 0.05 (p = .000)
indicating that there was an increase in macular thickness after cataract surgery. It was
concluded that macular thickness was higher in patients having mild non-proliferative
diabetic retinopathy without taking nepafenac following cataract surgery.
Another study was conducted by Chen et al in 2016 to estimate the incidence of development
of macular edema in diabetic eyes with or without pre-existing macular edema using optical
coherence tomography. At the 1st and 3rd follow-ups, the mean central macular thickness was
increased by 21.0 µm and 25.5 µm, respectively (P<0.01). Average increases in inner and
outer ring thickness were 14.2 µm and 9.5 µm at 1 month, and 18.2 µm and 12.9 µm at 3
months. It was concluded that the central subfield, perifoveal and parafoveal sectors, all
showed statistically significant increase in thickness of macula following cataract surgery
(20). In present study the mean value of macular thickness in moderate non-proliferative
diabetic retinopathy patients not taking nepafenac at preoperatively, one week, one month
following cataract surgery was and 258.06 + 13.88, 274.00 + 14.25 and 282.06 + 17.92
respectively and p value was less than 0.05 (.000). It was concluded that macular thickness
was higher in patients having moderate non-proliferative diabetic retinopathy not taking
nepafenac following cataract surgery.

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Another study was conducted by Sarfraz et al in 2017 to assess the effectiveness of topical
Nepafenac (0.1%) post-operatively in the prevention of macular edema after cataract surgery
in individuals with non-proliferative diabetic retinopathy. The mean pre-operative central
macular thickness , 3 months post-operative central macular thickness, mean change in CMT,
and mean frequency change in CMT of patients taking nepafenac were 226.5+10.86m,
228.83+14.56 m, 2.33+10.45 m, and 1.05%, respectively. It was concluded that topical
Nepafenac 0.1% is effective in preventing macular edema following cataract surgery in
patients with non-proliferative diabetic retinopathy (NPDR) (21). In current study, non-
proliferative diabetic retinopathy was further categorized to mild and moderate NPDR. The
impact of nepafenac 0.3% on macular thickness was assessed in both groups. The mean
macular thickness pre-operatively, one week, and one month following cataract surgery was
228.20 + 7.02, 224.40 + 9.78 and 216.2267 + 9.0507 respectively in patients using nepafenac
with mild non-proliferative diabetic retinopathy. It was concluded that topical nepafenac
0.3% ophthalmic suspension was found more effective in reducing macular thickness in
diabetic patients with mild non- proliferative diabetic retinopathy following cataract surgery.
A research was done in year 2020 by Sahin et al to find out the effectiveness of nepafenac
0.1% eye drops in prevention of macular edema after the cataract removal. Participants who
received topical nepafenac preoperatively has less increases in macular thickness in the
central 1 mm region after 3 and 6 weeks with P=0.028 and 0.008, respectively). There was
no significant increase in central macular thickness in patients taking 0.1% nepafenac. The
results showed that topical steroids and nepafenac 0.1% treatment following cataract surgery
reduced the early postoperative increase in macular thickness (22). In current study,
participants who received 0.3% nepafenac ophthalmic suspension pre-operatively and
postoperatively after one week and one month had reduced increase in macular thickness as
compared to the group not taking nepafenac. The p value at baseline, one week, one month
following cataract surgery in moderate non-proliferative diabetic retinopathy patients taking
nepafenac was (p= .000). It was concluded that topical nepafenac 0.3% ophthalmic
suspension was found more effective in reducing macular thickness in moderate non-
proliferative diabetic retinopathy following cataract surgery.

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5.2: CONCLUSION
• It was concluded that topical nepafenac 0.3% ophthalmic suspension was found more
effective in reducing macular thickness in diabetic patients with mild and moderate non-
proliferative diabetic retinopathy following cataract surgery.
• It was concluded that macular thickness was increased in mild and moderate non-
proliferative diabetic retinopathy following cataract surgery in patients without taking
nepafenac.
This study revealed that prevention is considerably safer and less expensive than invasive
procedures like intravitreal or periocular injections, which may be used to treat diabetic
individuals with macular edema following cataract surgery. Therefore professionals should
educate the patient how to minimize the complications of diabetic retinopathy.
5.3: LIMITATIONS
• Difficulty in collecting the data at follow ups as patient hardly came for follow ups.
• It was difficult to ensure that all participants adhere consistently to the prescribed dosage
and administration schedule, which could influence the study's results.
5.4: RECOMMENDATIONS
• Nepafenac is a cheap and effective treatment for prevention of cystoid macular edema in
patients with mild and moderate diabetic retinopathy patient following cataract surgery.
• Physician should prescribe 0.3% nepafenac instead of more expensive treatment options
along with conventional treatment.
• Nepafenac is an anti-inflammatory drug that reduces postoperative inflammation,
minimizing pain, and accelerating healing.
• Nepafenac eye drops help the visual recovery process after cataract surgery by reducing
inflammation, avoiding macular edema, and preventing CME. It is possible to restore
clear and precise vision more quickly by eliminating these potential complications.
• Additional research should be conducted on the effectiveness of nepafenac in reducing
inflammation and pain after intra ocular lens removal.

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