A hospital based cross sectional study on determining of prevalence

and risk factors of eye disease among diabetes in a teaching tertiary

care hospital in India
Senthilvel Vasudevan1 , Amitha Prasad2
1Assistant
Professor of Statistics, Department of Pharmacy Practice, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi
Arabia. 2Biostatistician Technician, IQVIA, World Trade Center Kochi (Brigarde), 7 th floor, Tower A, Info Park SEZ, Info Park Phase-1
Campus, Kakkanad, Kochi, Kerala, India.

Abstract
Background: This study aimed to determine the prevalence of Diabetic Retinopathy and to find the associated risk factors of DR among
known Type II DM patients.
Materials and Methods: A hospital-based cross-sectional and single center study was conducted among Type II DM patients with and
without DR in the department of Endocrinology with a sample size of 150 with DM patients in 2018. Data were expressed as mean, standard
deviation, proportions, Chi-Square, t-test test and Binary Logistic Regression analysis.
Results: Diabetic patients 150 were identified as Type II DM as per inclusion criteria with aged 30 years and above. Among 150 Diabetic
patients, 39 (26%) patients had Diabetic Retinopathy and 111 (74%) patients were not having Diabetic Retinopathy. The association between
groups (with and no DR) and duration of DM were very highly significant with p-value < 0.01. DR prevalence was higher in female when
compared with male population.
Conclusion: From our study, we have concluded that the prevalence of DR was very high. DR was strongly associated with HbA1C, FBS,
duration of DM, medication, duration of hypertension and smoking. Hence, there is a need for regular screening check-up with
ophthalmologist to prevent diabetic retinopathy or to prolong or to escape from the vision loss.

Keywords: type II diabetic mellitus, diabetic retinopathy, prevalence, risk factors

Article Summary: Submitted: 08-January-2022 Revised: 06-February-2022 Accepted: 22-March-2022 Published: 31-March-2022
Quick Response Code: This is an open access journal, and articles are distributed under the terms of the
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are licensed under the identical terms.
DOI: Corresponding Author: Dr. Senthilvel Vasudevan,
10.55349/ijmsnr.2022.211016 Department of Pharmacy Practice, College of Pharmacy,
King Saud Bin Abdulaziz University for Health Sciences, Riyadh,
Saudi Arabia. Email ID: vasudevans@ksau-hs.edu.sa

Introduction
Diabetes mellitus (DM) is commonly called as diabetes, it is a chronic disease [1] and it is caused by the deficiency in the production of
insulin by pancreas or by a deficit of the insulin produced in the human body. DM is a metabolic disorder in which there are high blood
sugar levels over a long period in the human blood. DM causes morbidity and mortality about 180 million people worldwide [1, 2]. In some
of the studies, the blindness from diabetes is almost entirely preventable with early diagnosis, controlling the risk factors and timely
treatments with ophthalmologist [3, 4]. It is a public health problem both in developing and developed countries. The disease is classified
into two according to the distinct groups of patients. They are type I diabetes and type II diabetes. Its prevalence is getting increased day by
day due to variations have taken place in both demographic and epidemiology as a result of urbanization, industrialization, and
globalization. Its prevalence is calculated to increase from 4% in 1995 to 5.4% by 2025. While considering diabetes prevalence, there is a
42% and 170% increase in both developed and developing countries. As per the new statistical result, there are approximately 33 million
diabetic adults in India. India is becoming as diabetes mellitus patients’ capital of the world within the year 2025 predicted by Wild et al
[5].
Diabetic Retinopathy (DR) is a microvascular complication of diabetes mellitus [6]. DR causes complete blindness in both developing and
developed countries. There is 25 times chance of getting blindness in diabetics than non-diabetics. Though Diabetes Mellitus causes many
microvascular complications, retinopathy is considered to be the main morbidity as it threatens vision. DR is causing blindness in the world

How to cite this article: Vasudevan S, Prasad A. A hospital based cross sectional study on determining of prevalence and risk
factors of eye disease among diabetes in a teaching tertiary care hospital in India. Int J Med Sci and Nurs Res 2022;2(1):10-16
Int J Sci and Med Res 2021;1(2):1–9

International Journal of Medical Sciences and Nursing Research 2022;2(1):10-16 Page No: 10
 Vasudevan S et al., Study on determining of prevalence and risk factors of eye disease among diabetes

level and 70% people were affected those who were living in under from 1st February to March 2nd, 2018 with a sample size of 150
developing income countries [7, 8]. Diabetic Retinopathy is a dreadful known Type II DM patients with census sampling method.
complication and every part of the eye will be affected. The factors
responsible for the development of DR were duration of diabetes, poor Selection of patients for the study: Totally, 350 patients were
glycemic control, age and gender, hypertension, nephropathy, genetics, screened in our study. In that, 200 were DM patients 150 were
serum lipids, anemia, puberty, socioeconomic status, pregnancy [4, 9, 10 identified as Type II DM as per inclusion criteria. Patients those
and 11]. Duration of DM and glycemic control has a direct and indirect who were under diabetes came and under treatment for DM was
relationship between DR. Hypertension is also increasing the risk of DR consecutively selected by an ophthalmologist were included in our
in a Type II DM patients. The objectives of our present study were to present study Figure – 1. DM Patients were screened, automated
determine the prevalence of Diabetic Retinopathy among known Type II diagnosis and grading of DR by using Optical Coherence
DM patients and to find the associated risk factors of DR among known Tomography by a trained Ophthalmologist. Some of the patient’s
Type II DM patients. data were collected from the hospital records and some data from
the patients directly. An inclusion criterion of the patients with
Materials and Methods aged 30 years and above those who were having DM for at least one
year and above and who are all the residence of Kochi area, Kerala,
We have done a hospital based cross-sectional study among known Type South India and with an exclusion criterion the patients those who
2 DM patients on DR in the department of Endocrinology and retina were having chronic diseases and not willing to participate in our
center, Amrita Institute of Medical Sciences, Ponekkara, Kochi, Kerala present study.

Figure: 1 Distribution of basic and clinical characteristics among Type II Diabetes Mellitus patients

International Journal of Medical Scienscs and Nursing Research 2022;2(1):10-16 Page No:11
Vasudevan S et al., Study on determining of prevalence and risk factors of eye disease among diabetes

Major divisions of Diabetic Retinopathy: Normal human eye with Results

clear retina and those who are affected by eye threatening disease DR
in the Type II DM patients’ eye is having black dots and Totally 350 patients were screened by a trained ophthalmologist
hemorrhages. DR can be divided into two broader areas: (1). Non- in our present study. Among 350 patients, 200 were Diabetic
proliferative Diabetic retinopathy (NPDR) and (2). Proliferative Mellitus only and 150 were various other diseases of Type II DM
Diabetic retinopathy (PDR). patients. Among 150 Type II DM patients, 85 (56.7%) were males
and 65 (43.3%) were females. The mean age of the participants
Classifications of Diabetic Retinopathy: Early Treatment Diabetic was found as 58.15 ± 10.46 (Range: 31 to 87) years. Out 150
Retinopathy Study Research Group has classified NPDR into mild, known Type II DM patients 39 (26.0%) were identified as DR
moderate, severe and very severe and PDR into early PDR and high- and 111 (74.0%) weren’t had DR. So, the overall prevalence of
risk PDR. Further classifications are as follows: (a). Mild Non- DR was found as 26% in the study population and other socio-
proliferative diabetic retinopathy; (b). Moderate Non-proliferative economic variables were as shown in Table – 1.
diabetic retinopathy; (c). Severe Non-proliferative diabetic
retinopathy; (d). Very severe Non-proliferative diabetic retinopathy; Out of 123 normal total cholesterol patients, 87 (70.7%) patients
(e). Early proliferative diabetic retinopathy; (f). High-risk PDR. If a weren’t having DR (without DR) and 36 (29.3%) were having DR
patient hasn’t treated in time is at high risk of severe then he will (with DR) and in 27 abnormal total cholesterol patients, 24
definitely get the visual loss the Diabetic Retinopathy Study Research (88.9%) were without DR and 3 (11.1%) were with DR which
Group (1981). In our study, we have divided DR stages as No DR, was statistically merely significant with p=0.05. In medication,
Mild DR, Moderate DR, Severe DR and PDR as per Diabetic out of 93 tablet taking patients, 82 (88.2%) patients were not
Retinopathy PPP-Updated (2017). With the advancement of DR, the having DR and 11 (11.8%) were with DR and in 57 insulin taking
quality of life of patients diminishes, and the financial burden of society patients, 29 (50.9%) were without DR and 28 (49.1%) were with
rises, both in the DR screening and treatment groups. DR has been DR and total cholesterol which were very highly significant with
found to be correlated with many other diabetes-related complications p<0.001 except the variables like age, gender, body mass index
like nephropathy, peripheral neuropathy, low bone density, and (BMI), history of hypertension, fasting blood sugar (FBS),
cardiovascular events, all of which decreases the quality of life and educational status, family history of DM, smoking habit, alcohol
cause a high rate of mortality in Early Treatment Diabetic Retinopathy consumption, duration of hypertension, duration of DM, HbA1C
Study Research Group (1991). Hence, it is recommended for early which weren’t significant with p-value > 0.05. 39 DR patients
diagnosis and proper management by Wild et al (2004). Variables mean duration of DM was 16.6 ± 7.6 years and mean duration for
were included in the study, gender, age, educational Status, family the without DR group was 10.21 ± 6.7 years, which was very
history of DM, smoking habit, alcohol consumption, history of highly significant with p<0.01, 39 DR patients mean HbA1C was
hypertension, medication, total cholesterol level, duration of 8.94 ± 2.1% and the mean HbA1C of 111 without DR group was
hypertension, body mass index (BMI), duration of DM, fasting blood 7.97±1.8%, which was highly significant with p<0.01, 35 DR
sugar (FBS), and hba1c. The data were collected by using a structured patients mean FBS was 160.25 ± 55.8 and the mean FBS of 100
and tested questionnaire. without DR group was 136.84 ± 44.3 which was significant with
p<0.05 and age wasn’t significant with p>0.05 as shown in Table
Data entry, its Management and Statistical Analysis: – 1.

The collected data were compiled by using Microsoft Excel 2010 The duration since diagnosis of DM was < 10 years in 42.7%, ≥
(Office 365, Microsoft Ltd., USA) and analyzed by using Statistical 10 years in 34.9% and ≥ 15 years in 39.3%. The association
Package for Social Sciences 20.0 version (SPSS Inc. Chicago, USA). between groups (with and without DR) and duration of DM were
The continuous data were mentioned as mean, standard deviation and very highly significant with p-value < 0.01 as shown in Figure –
categorical data were mentioned as frequency and proportions. In 2.
bivariate analysis, to compare the mean difference between continuous
variables between groups by using independent samples t-test, to find Figure – 2 Association between duration of diabetic
the association between variables by using Chi-Square test and found mellitus and with and without diabetic retinopathy
the significant variables. In multivariate analysis, we have used binary
logistic regression (BLR) analysis. The significant variables were
obtained by bivariate analysis and p – value ≤ 0.20 were identified and
included in the final BLR analysis with back ward elimination method
and found the risk factors to develop DR among known Type II DM
patients. The statistical significance was fixed at p-value less than 0.05.

Ethical approval and consent to participate:

This study was done with prior permission was obtained from Amrita
Institute of Medical Sciences, Kochi before conducting this study.
Ethical approval from the Institutional Ethical Committee of AIMS has
been obtained and informed written consent was taken from all
participants in the study.

International Journal of Medical Scienscs and Nursing Research 2022;2(1):10-16 Page No: 12
Vasudevan S et al., Study on determining of prevalence and risk factors of eye disease among diabetes

Table: 1 Distribution of basic and clinical characteristics among Type II Diabetes Mellitus patients

No. of Diabetic Retinopathy

Variables P – value$
Patients With DR Without DR
Gender Male 85 (56.7)
20 (23.5) 65 (76.5)
0.430#
Female 65 (43.3) 19 (29.2) 46 (70.8)
Age (in years) Age (Mean ± SD) 58.15 ± 10.46 (Range: 31 – 87) years

Age groups (in years) ≤ 50 34 (22.7)

60.38 9.06
0.122#†
> 50 116 (77.3)
57.37 10.84
Educational Status School 91 (60.7) 23 (25.3) 68 (74.7)
College 0.801#
59 (39.3) 16 (27.1) 43 (72.9)
Family History of DM Yes 9 (19.1) 38 (80.9)
47 (31.3)
No 0.196#
103 (68.7) 30 (29.1) 73 (70.9)
Smoking Habit Yes 33 (24.3) 103 (75.7)
136 (90.7)
0.131#
No 6 (42.9) 8 (57.1)
14 (9.3)
Alcohol Consumption Yes 32 (25.2) 95 (74.8)
127 (84.7)
0.598#
No 7 (30.4) 16 (69.6)
23 (15.3)
History of hypertension Yes 8 (14.5) 47 (85.5)
55 (36.7)
No 0.616#
95 (63.3) 31 (32.6) 64 (67.4)
Medication Tablet Users 11 (11.8) 82 (88.2)
93 (62.0)
Insulin Users 0.0001**
57 (16.0) 28 (49.1) 29 (50.9)
Duration of DM < 10 years
64 (42.7) 16.62 7.57
≥ 10 years 0.0001**†
86 (57.3) 10.21 6.65
BMI Classifications 18.5 – 24.9 (Normal) 17 (24.6) 52 (75.4)
68 (45.3)
25.0 – 29.9 (Over Weight) 0.726#
82 (54.7) 22 (27.2) 59 (72.8)
Total Cholesterol Normal 123 (82.0) 36 (29.3) 87 (70.7)
0.056*
Abnormal 27 (18.0) 3 (11.1) 24 (88.9)
HbA1C (in %) ≤ 6.5
30 (20.0) 8.94 2.12
> 6.5 0.007**†
120 (80.0) 7.97 1.83
Fasting Blood Sugar ~ Normal 14 (10.4) 2 (14.3) 12 (85.7)
0.013*
Abnormal 121 (89.6) 33 (27.3) 88 (72.7)
$
Chi Square Test P – value; †t – test P – value; **P – value < 0.01 Highly Significant; *P – value < 0.05 Significant;
#
P – value > 0.05 Not Significant; ~Missing value occurred

International Journal of Medical Scienscs and Nursing Research 2022;2(1):10-16 Page No: 13
 Vasudevan S et al., Study on determining of prevalence and risk factors of eye disease among diabetes

We have used Binary Logistic Regression equation with backward of DR is found to be older female patients with longer disease. The
conditional analysis to predict the influencing factor to develop the similar type results of risk factors for DR and DR progression were
diabetic retinopathy among known Type II DM patients. From binary found in older female patients with longer disease in our present
logistic regression, the above results were obtained and Hosmer- study also. In addition, having renal complications of diabetes,
Lemeshow test was showed a goodness of fit with Chi-Square value poor glycemic control, hypertension was also identified as the risk
was 2.891 and the corresponding p-value was 0.941 which wasn’t factors for DR. Among these identified factors, duration of DM,
statistically significant with p-value > 0.05. Therefore, from this we hyperglycemia, and hypertension were considered to be the most
have concluded that the Chi-Square value wasn’t significant and this affecting risk factors for advancement vision loss. Nevertheless,
was proved the model was a good fit. ie., the selected variables are DR and risk factors of DR hardly gained any attention and the
perfectly fit to that binary logistic regression equation model approach. concurrence with the eye screening is often poor was mentioned by
The history of hypertension wasn’t significant in the bivariate analysis Early Treatment Diabetic Retinopathy Study Research Group
but included in the final BLR analysis. Finally, we have got in the [4]. Abnormal glucose metabolism has led to an increase in the
backward elimination step-3, the variables HbA1C, FBS, smoking prevalence rate of DM as well as DR. In our study, the prevalence
habit, intake of tablet/insulin, duration of DM and history of of DR in the study population was found as 26%. Raman et al [13]
hypertension are significant with p-value <0.05 except age and total have revealed that the prevalence of DR among DM patients was
Cholesterol. The included variables and their odds ratio, significance 10.3%. However, Xu et al. [14] have found 24.7% as overall
and 95% Confidence Interval were as shown in Table – 2. prevalence among Beijing population, China. Whereas, the
prevalence of DR was 11.9% in another one study from
Discussion Northeastern area of China by Hu et. al. [15]. In another one study
by Looker et al. [16] the prevalence of any DR at their first
Diabetic Retinopathy (DR) is a common disease in Type II Diabetes screening was found as 19.3%. Moreover, in some other studies the
Mellitus (DM) patients [12]. In some epidemiological studies on DR prevalence of DR was found by Pamu et al. [17] 41%, Giri et al.
including both cross-sectional and cohort studies have conducted [18] 44.4%, Liu et al. [19] 34.1%, Ahmed et al. [20] 36.4%, Zhang
worldwide. Their intention was to explore the risk factors that were et al. [21] 27.9%. Furthermore, the prevalence of DR in our study
associated with the disease and on the prevention and management of was higher than those documented in other studies 21.7% by
this disease [20]. The greater risk factor for DR and progression Gadkari et al. [22] and 18% by Kim et al. [10].

Table – 2 Distribution of prediction variables in the multivariate analysis equation, its significance,
odds ratios and 95% Confidence Interval (N = 150)

95% CI
Prediction Variables in the
AOR Significance
equation
Lower Upper

Age 0.97 0.296# 0.92 1.03

Smoking habit 15.39 0.002** 2.66 89.18

Duration of Diabetes Mellitus 1.18 0.001** 1.07 1.31

HbA1C 1.34 0.035* 1.02 1.75

Fasting Blood Sugar 1.01 0.027* 1.00 1.02

Medication 5.72 0.002** 1.93 16.91

History of Hypertension 1.10 0.016* 1.02 1.18

Total Cholesterol 5.86 0.065# 0.90 38.41

AOR – Adjusted Odds Ratio; 95% CI: 95% Confidence Interval; **P – value < 0.01 Highly Statistically Significant;
*P – value < 0.05 Statistically Significant; #P – value > 0.05 Statistically Not Significant

International Journal of Medical Scienscs and Nursing Research 2022;2(1):10-16 Page No: 14
 Vasudevan S et al., Study on determining of prevalence and risk factors of eye disease among diabetes

The difference in the prevalence rate is due to the fact in that many of
eliminated. The strongest predictors were HbA1C, FBS, smoking
the studies were population-based and due to the different screening
habit, medication (intake of tablet/insulin), duration of DM, and
techniques adopted. The mean age of the participants was a little bit
history of hypertension was eliminated from the third step of BLR
high than a study was conducted in Pondicherry, South India by
analysis. A similar study was conducted to estimate the strongest
Vasudevan et. al. [11]. Furthermore, the similar type of results was
predictors by Ahmed et al. [20] and Pradeepa et al. [27].
mentioned in another one study on the prevalence of DR and its
associated factors in a rural area of Tamil Nadu, South India was done
In a study by Gadkari et al. [22] has resulted that the prevalence was
by Nadarajan et. al. [23] Whereas the mean age of the participants was
found more in males, DM was happened after 5 years, DM patients
found as very high 69.2 ± 8.5 years in a study by Wang et al [24] in
was in above 40 years, insulin users and history of vascular
Guangzhou, China. DR prevalence is higher in the female when
accidents. But our study, the prevalence was more in males among
compared with male population. The similar type of results has been
females, DM more than 10 years, those aged above 50 years. We
mentioned in a Chennai Urban Rural Epidemiology Study (CURES)
didn’t take into an account of the history of vascular accidents. A
Eye Study-I by Rema et al. [25]. In our study, we have found that the
Korean study by Kim et al. [10] has showed that the odds ratio of
mean duration of DM was 16.62 ± 7.6 years. In our present study,
the DR increased with duration of DM, postprandial glucose levels,
34.9% of DM patients had DR for 10 years and above and 14.1% of
and HbA1C and in our study odds ratio was also increased with
DM patients had DR less than or equal to 10 years. The test was
smoking habit, medication, and HbA1C. Kohner et al. [28] has
statistically highly significant with p-value < 0.01 as shown in Figure
mentioned in their study that the presence of retinopathy was the
– 2. Whereas one study from Karnataka by Nayak et al. [26] have
same percentage in both the male and female and fasting plasma
mentioned the very high prevalence of DR as mentioned half percentage
glucose level was the risk factor for developing DR. We have also
for more than 10 years and a similar percentage were having DM more
found the same type of results in our present study. So, the
than 5 years. Retinopathy increases with younger age at onset of
ophthalmologic examination is needed for all known Type II DM
diabetes and showed a significant association between DR and duration
patients for the management and treatment of DR for every year
of diabetes, which is consistent with most of the previous studies Pamu
from the diagnosis date of DM.
et al. [17], Giri et al. [18], Liu et al. [19] and Ahmed et al. [20]. The
risk factors like duration of DM, HbA1C, FBS, history of hypertension
and medication also showed a higher significance with DR. However, Conclusion
we didn’t find any significant association between DR and age, gender,
education, family history of DM, total cholesterol and BMI. Similarly, From this present study, we have concluded that the prevalence of
a study by Liu et al. [19] also didn’t find any association with gender DR among Type II DM patients was high. There is a need of
but showed association with duration of the disease. necessary and immediate steps/actions need to be taken to reduce
the prevalence through the Government, medical institutions and
Out of the 150 known Type II DM patients, 85 were males and 55 were other Non-Government organizations. Retinopathy is strongly
females. Among that 23.5% of the males and 29.2% of the females associated with Hemoglobin A1C, fasting blood sugar, duration of
were affected by DR. The age group of the study ranged from 31–84 DM, medication, duration of hypertension and smoking. So, there
years. Majority of the patients in our study were aged above 50 years is a need of regular check-up for known Type II DM patients to
and DR was also found in the mean age of 60.38 ± 9.06. But the study prevent DR. Further studies are needed in this area and health
by Pamu et al. [17] has shown a slight male preponderance in all age education is necessary to create awareness among DM patients.
groups and the majority of DM patients in the age group of 41–50
years. Risk factors like BMI, hypertension, HbA1C, duration of DM Availability of data and materials: Patients’ data were
and microalbuminuria were identified as statistically significant in their confidential and preserved by the institution.
study. A similar type of results was found in our study that history of
hypertension, HbA1C, and duration of DM were significant with p- Source of Funding: The authors haven’t get any type of
value < 0.05. More than half of the study population was having funding from the parent institution, or any other financial
hypertension and higher proportion of DR was seen among institutions.
hypertensive patients (32.6%) than non-hypertensive patients (14.5%),
which was significant with p-value < 0.05. Similar result was found in Conflict of Interest: The authors are not having any kind of
the study by Giri et al. [18] also. conflict of interest.

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