RELATION OF HYPERTENSIVE RETINOPATHY WITH DURATION AND CONTROL OF

HYPERTENSION AMONG NON-DIABETIC HYPERTENSIVE PATIENT.

Hypertension - or elevated blood pressure - is a serious medical condition that significantly

increases the risks of heart, brain, kidney and other diseases. An estimated 1.13 billion people
worldwide have hypertension, most (two-thirds) living in low- and middle-income countries. In
2015, 1 in 4 men and 1 in 5 women had hypertension. Fewer than 1 in 5 people with
hypertension have the problem under control. 1 Hypertension is a major public health problem
across the world and is the world’s leading cause of death, killing around 10.7 million people
every year, more than all infectious diseases combined.2 According to systemic review and
metaanalysis done by Yun Huang et.al in 2019, the estimated rate of hypertension and
prehypertension in Nepal were found to be 27.3% (95% CI: 23.8–30.9) and 35.4% (30.3–40.8).5

According to International Society of Hypertension 2020 guideline, Hypertension is diagnosed

when resting blood pressure under optimal condition is more than 140/90 measured 2 -3 times in
2 or more office visits. Normal BP is BP< 130(systolic)/< 85 (diastolic), high-normal BP is
130–139 (systolic) and /or 85–89 (diastolic), Grade 1 hypertension is 140–159 (systolic) and/or
90–99 (diastolic) and Grade 2 hypertension is≥160 and/or ≥100. It is known as uncontrolled if
SBP is ≥140 mm Hg and/or DBP ≥90 mm Hg for general hypertensive population, or SBP ≥130
mm Hg and/or DBP ≥80 mm Hg in patients with established diabetes mellitus (DM) or chronic
kidney disease (CKD) after 3 months of active intervention in form of drugs or lifestyle
intervention or both. 3According to nationwide STEPS survey 2014 , the prevalence of raised
blood pressure in Nepal, including those who were on medication for hypertension was 26%.4

The heart, kidney, brain, eye and arterial blood vessels are prime targets of hypertension
mediated organ damage. Uncontrolled hypertension accelerates the damage to these organs and
results in eventual organ failure disability and death. 6 Hypertensive retinopathy is among the
vascular complications of essential hypertension. It is observed that the auto-regulation of retinal
circulation fails as blood pressure increases beyond a critical limit.7

Hypertensive retinal changes include vascular narrowing, arteriovenous changes, occlusion, and
exudation. In severe hypertension, increased retinal hemorrhages and optic nerve head swelling
may be observed.8 Severe grades of retinopathy can be an indicator of renal morbidity, whereas
earlier grades of retinopathy can be predictor of acute cerebrovascular events. 8 Keith-Wagner-
Barker classification classification systems for hypertensive retinopathy is based on fundus
examination with indirect ophthalmoscopy or +90 D lens.

Keith-Wagner- Barker classification

Group 1: Slight constriction of retinal arterioles

Group 2: Group 1 + focal narrowing of retinal arterioles + AV nicking

Group 3: Group 2 + flame-shaped haemorrhages + cotton-wool spots + hard exudates

Group 4: Group 3 + optic disc swelling

Modi P, Arsiwalla T. Hypertensive Retinopathy. [Updated 2020 Jul 10]. In: StatPearls [Internet].
Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK525980/

There are limited studies about prevalence of hypertensive retinopathy among hypertensive
patient and its association with control and duration of hypertension. According to the Bhaktapur
retina study done by Thapa et.al the prevalence of hypertensive retinopathy among hypertensive
patient was 12.6%.9The study done by CB Pun et.al in western part of Nepal in a tertiary
hospital of Gandaki Medical College pokhara showed 56.5% hypertensive patients had
hypertensive retinopathy. Of which 31% had grade I, 19% had grade II, 6% had grade III and
0.5% had grade IV hypertensive retinopathy. 10 In a similar study done by Godar et.al in a tertiary
hospital of Nepal among hypertensive patient visiting the out patient department, the prevalence
of hypertensive retinopathy was 38.95%. Among the patients with hypertensive retinopathy, the
prevalence of grade I, II, III and IV retinopathies were 7.36%, 17.89%, 10.52 and 3.15%
respectively.11A study done by Karki et.al in Kathmandu based tertiary hospital in Kathmandu
Medical College showed prevalence of 52.31% among 302 hypertensive patient visiting
outpatient department.12

In a study done in Eastern Nepal in a tertiary hospital, BPKIHS among 255 study participants
with hypertension, 52 (20.4%) patients had at least one of the two subclinical target organ
damage (left ventricular hypertrophy and renal insufficiency). The organ most affected was the
heart presenting as left ventricular hypertrophy observed in 48 (18.8%) followed by renal
insufficiency in 35 (13.7%) patients. The duration of hypertension, smoking habit, uncontrolled
blood pressure, irregular use of antihypertensive medications and obesity were positively related
to the occurrence of HMODs.13

On the basis of search in Google scholar, Pubmed, Hinari and journal of Nepal Medical
Association, studies of prevalence of hypertensive retinopathy, and its relation with duration and
control of hypertension are lacking in our population. This study aims to determine distribution
of hypertensive retinopathy among hypertensive patients, explore any association between
hypertensive retinopathy with duration and control of hypertension. Furthermore, this study will
find out the relation of hypertensive retinopathy with other target organ damage and different
known risk factors of hypertension. So, this study may open the door of some evidence of
possible causal association of hypertensive retinopathy with duration and control of hypertension
and may guide further to help select a population at risk for aggressive risk factor reduction and
treatment.

Literature Review

Kibria et.al et al in the year 2017 analyzed NDHS 2016, a nationally representative survey to
estimate the prevalence and associated factors of pre‐hypertension and hypertension in Nepal. A
total of 14,857 individuals (6247 males and 8610 females) aged ≥15 years who had their blood
pressure measured during the survey were included in this study. The prevalence for pre‐
hypertension and hypertension were 26.0% (95% CI: 25.3‐26.3, n = 3856) and 19.5% (95% CI:
18.8‐20.2, n = 2899), respectively. For hypertensive people, the median SBP was 141 (IQR: 129‐
154) mm Hg, and the median DBP was 93 (IQR: 89‐99) mm Hg. Hypertensive participants were
older (median: 51, IQR: 38‐62 years) than their pre‐hypertensive (median: 38, IQR: 26 ‐52 years)
or normotensive (median: 28, IQR: 20‐43 years) counterparts. The percentage of the overall
population and hypertensive people who were taking blood pressure lowering medication were
3.9% and 20.5%, respectively (n = 585 for both). About half of the participants (48.6%) were
below 35 years of age. Although the proportion of people ≥65 years of age was 10.0% (1483/14
857), this proportion was 22.0% (n = 638) among hypertensive persons (n = 2889). On the other
hand, among the respondents who were on anti‐hypertensive medication (n = 585), nearly half
had uncontrolled hypertension, 47.8% (95% CI: 43.8‐51.8). The overall prevalence of “stage 1”
and “stage 2” hypertension was 13.5% (95% CI: 12.9‐14.0) and 6.0% (95% CI: 5.6 ‐6.4),
respectively.

A institution based cross-sectional study was done by Tesfaye et al in the year 2017 in Ethiopia
which included 345 hypertensive patient. More than half, 52.7%, of the patients had uncontrolled
hypertension. Lack of awareness of hypertension-related complications (adjusted odds ratio
[AOR]=2.140, 95% confidence interval [CI]=1.272–3.600, p=0.004), nonadherent to smoking
abstinence (AOR=3.935, 95% CI=1.065–14.535, p=0.004), nonadherent to alcohol abstinence
(AOR=2.477, 95% CI=1.074–5.711, p=033), Khat (Catha edulis) chewing (AOR=2.518, 95%
CI=1.250–5.073, p=0.010), overweight (AOR=2.241, 95% CI=1.239–4.053, p=0.008), middle
age (AOR=7.893, 95% CI=1.860–33.493, p=0.008), and old age (AOR=9.944, 95% CI=2.523–
39.188, p=0.001 were significant predictors of uncontrolled hypertension.

In a cross-sectional descriptive study done by Cuspidi et.al in Italy , total of 2172 nondiabetic
untreated and treated uncomplicated essential hypertensives consecutively attending for the first
time hospital outpatient hypertension clinic and included in the Evaluation of Target Organ
Damage in Hypertension (ETODH), were analysed for target organ damage. Among the whole
study population, 33 patients (1.5%) were found to have advanced hypertensive retinopathy.
Patients with these retinal lesions were similar to those without for age, body mass index, known
duration of hypertension, smoking habit, total serum cholesterol, fasting blood glucose and
prevalence of antihypertensive treatment; whereas mean systolic and diastolic blood pressures
were higher in the former group. The prevalence rates of LVH, carotid plaques, carotid IM
thickening and microalbuminuria in patients with and without retinopathy were 57%, 67%, 69%,
19% and 25%, 47%, 44%, 12%, respectively. In a multivariate logistic regression analysis,
advanced retinopathy was significantly associated with LVH (OR54.0), carotid IM thickening
(OR52.9), carotid plaques (OR52.8), but not with microalbuminuria.

Ray et al conducted a descriptive cross-sectional study in India among 416 hypertensive patients
with known cerbrovascular, cardiovascular or renal co-morbidities. Hypertensive retinopathy
was present in 259 patients (62.25%) out of 416 participants (Grade I: 13.5%, Grade II: 26.9%,
Grade III: 18.5%, and Grade IV: 3.4%). Among the variables associated with hypertensive
retinopathy, it was seen that 209 (63.3%) subjects present with features of hypertensive
retinopathy are more than 50 years of age. No significant association was found between
hypertensive retinopathy and presence or absence of cardiovascular morbidities, cerebrovascular
morbidities, and renal morbidities. However, the subgroup analysis shows that significant
association was found between Grade IV hypertensive retinopathy with renal morbidities (odds
ratio [OR] = 5.83 at 95% CI, P = 0.002) and Grade I retinopathy with cerebrovascular
morbidities (OR = 7.09 at 95% CI, P = 0.000). It suggested that severe grades of retinopathy can
be an indicator of renal morbidity, whereas earlier grades of retinopathy can be predictor of acute
cerebrovascular events.

In a similar cross-sectional study done by Gupta et.al including 100 hypertensive patients with
dyslipidemia, 69 (69%) had retinopathy and the remaining 31 (31%) subjects having retinopathy
were mainly concentrated in the 6th decade (69.70%), increasing thereafter up to 83.78% who
were over 60 years of age. It showed the increasing prevalence of hypertensive retinopathy with
increasing age. No sex preponderance toward developing retinopathy was found in this study (o
< 0.29). A positive correlation of hypertensive retinopathy was found with total cholesterol (P <
0.002), low-density lipoprotein (LDL)-cholesterol (P < 0.0001), Serum triglycerides (P < 0.01),
and an low-density lipoprotein: high-density lipoprotein (LDL: HDL) ratio (P < 0.002).

In another cross-sectional study done by Oluleye et.al in Nigeria, among 903 hypertensive
patient 175 (19.4%) patients had features of hypertensive retinopathy. LV hypertrophy was
found in 42 (27%) patients, while 60 (39%) patients had increased relative wall thickness. In this
study, bivariate analysis showed a correlation between LV relative wall thickness and severity of
retinopathy in both eyes (Spearman’s coefficient 0.6; P=0.0004).

Erden et.al carried out study in 655 hypertensive patients who were being followed up by
Internal Medicine Outpatient Clinic of Istanbul Medical Faculty. The parameters such as age,
gender, duration of hypertension, coexisting diseases, antihypertensive drugs, and smoking
histories were carefully noted. Retinal examinations were evaluated by the ophthalmologist and
the vascular findings were classified into stage I–IV according to Keith–Wagener–Barker
staging. This study shows that the degree and duration of hypertension increases the incidence of
retinopathy. Blood pressure was under control in nearly half of the patients (50.4%).
Hypertensive retinopathy rate was 66.3% (grade 1, 33.6%; grade 2, 32.7%). Age, duration of
hypertension, and systolic blood pressure levels were significant risk factors for retinopathy (P
= .048, P = .035, and P = .012, respectively). The average age of the patients with retinopathy
was significantly higher than the cases without retinopathy; the mean hypertension durations
were significantly longer (P = .048, P = .035) in both grade 1 and grade 2 groups of retinopathy.

In a study done by Kim et.al in total of 437 consecutive, hypertensive patients, referred to an
outpatient hospital clinic of Korean Catholic University , 38.7% (N = 169), had Grade 0 with
normal retinal change, 49.1%(N = 215,) had Grade I with arteriolar narrowing, 11.2% (N = 49,)
Grade II with arteriovenous crossings. The prevalence of Grade I and Grade II hypertensive
retinopathy was significantly higher than that of advanced hypertensive retinopathy. The grade
of hypertensive retinopathy was related to age, duration of hypertension, coronary artery disease
(CAD), and left ventricular hypertrophy (LVH). The hypertensive retinopathy Grade II was
significantly correlated with LVH (odds ratio (OR) 2.3, 95% confidence interval (CI) 1.21–4.44,
p < 0.05) and CAD (OR 4.2, 95% CI 1.97–8.95, p-<-0.001). Grade I and Grade II hypertensive
retinopathy are frequently observed in hypertensive patients compared to Grade III and IV
patients.

Duncan et.al did a prospective cohort study involving 560 hypertensive, middle aged men
enrolled in the Lipid Research Clinic’s Coronary Primary Prevention Trial. Signs of hypertensive
retinopathy (generalised and focal arteriolar narrowing, arteriovenous nicking, widened arteriolar
light reflex, retinal haemorrhage and exudates, microaneurysms, and disc swelling) were
evaluated by direct funduscopy during a baseline examination by study physicians. Incident
CHD events were ascertained from hospital records, necropsy reports, and death certificates, and
reviewed by a masked panel of cardiologists. There were 51 definite CHD events (definite CHD
deaths or myocardial infarctions) during a median follow up of 7.8 years. After adjusting for age,
blood pressure, electrocardiographic manifestations of left ventricular hypertrophy, cholesterol
levels and treatment, glucose and creatinine levels, and smoking status in proportional hazards
analysis, the presence of hypertensive retinopathy predicted a doubling of the risk of definite
CHD events (relative risk 2.1; 95% confidence interval (CI) 1.0 to 4.2 ). The presence of either
generalized or focal arteriolar narrowing predicted almost a tripling of the risk (relative risk 2.9;
95% CI 1.3 to 6.2). Associations were similar for stage 1 hypertension (systolic and diastolic
blood pressures of 140–159 and 90–99 mm Hg, respectively) and for other CHD end points. The
data support the concept that retinal microvascular changes are markers of blood pressure
damage and predicts CHD in high risk men, independent of blood pressure and CHD risk factors.
So, retinal examination may be useful in risk stratification and in the tailoring of hypertension
treatment decisions.
Another hospital based cross-sectional study conducted among 95 hypertensive patients aged 30
years and above was done by Godar et.al in tertiary care hospital of Western region of Nepal.
Detailed eye examination including fundus evaluation under mydriasis was done on all patients
and hypertensive retinopathy was graded according to Keith-Wagener-Barker classification. The
mean age of the study sample was 59.74±15.11 years. The prevalence of hypertensive
retinopathy was 38.95%. Among the patients with hypertensive retinopathy, the prevalence of
grade I, II, III and IV retinopathies were 7.36%, 17.89%, 10.52% and 3.15% respectively. There
was statistically significant association between hypertensive retinopathy and controlled blood
pressure and treatment of hypertension. However, there was no statistically significant
association between hypertensive retinopathy and gender, duration of hypertension, residence,
family history, history of smoking and diet.The study suggested that uncontrolled blood
pressure and untreated patients of hypertension were the significant risk factors for hypertensive
retinopathy.

Thapa et.al conducted population-based, cross-sectional study from 2013 to 2015 in Bhaktapur
district, Nepal. The sample size was 2100 subjects age 60 years and above. From this sample, all
diagnosed patients with hypertension were analyzed. A detailed history was obtained, and an
ocular examination was performed. Hypertension was found in 643 subjects (34.61%), of which
224 (12.04%) were newly diagnosed cases. Hypertensive retinopathy was found in 81 cases
(12.6%). Grade 1, grade 2, and grade 3 hypertensive retinopathy comprised 53 (65.43%), 19
(23.46%), and 9 (11.11%) cases, respectively. Hypertensive retinopathy was more frequent in the
age group 70-79 years (15.23%) compared to other age groups, among males (13.25%),
illiterates (13.56%), diabetics (16.49%), and those with body mass index (BMI) ≥25 kg/m2
(14%). However, none of the factors was found to be statistically significant. Among the subjects
with hypertension, awareness of hypertension’s effects on the eyes, retina and vision was found
in 13.84%, 8.4%, and 11.98% respectively.

A hospital based cross-sectional study was performed among 200 hypertensive patients visiting
eye OPD of Gandaki Medical college from Dec 2016 to Dec 2017 by Pun et al. Detailed eye
examination including fundus evaluation under mydriasis was done on all subjects and
hypertensive retinopathy was graded according to Keith, Wagner and Barker classification by
ophthalmologist using 90 dioptre lens. Patient having diabetes and other retinal diseases were
excluded from the study. In the study, mean age of the patients was 60.58 ±12.26 ratio of
hypertensive retinopathy among male and female was 1.7:1. 56.5% patients had hypertensive
retinopathy. Of which 31% had grade I, 19% had grade II, 6% had grade III and 0.5% had grade
IV hypertensive retinopathy.
RATIONALE:-

Hypertension affects vital organs of the body such as the eye, brain, kidney and heart leading to various
morbidities. Hypertension is a major risk factor for coronary heart diseases and stroke and has been a
silent killer of millions around the world each year. Hypertension is associated with various ocular
morbidities affecting both the anterior and posterior segments of the eye. Common eye problems
associated with hypertension are sub-conjunctival haemorrhage, retinal vein occlusion, retinal artery
occlusion, hypertensive retinopathy, ischemic optic neuropathy and cranial nerve palsy . Some of the eye
problems due to hypertension can lead to visual impairment and blindness when diagnosis or treatment is
delayed. Control of blood pressure and regular eye check-ups can help to reduce these complications..
Duration of hypertension, severity of hypertension, poor control of blood pressure, ageing, smoking,
concurrent hyperlipidaemia and high plasma level of endothelin-1 are major risk factors associated with
hypertensive retinopathy. Hypertensive retinopathy predicts the long-term risk of stroke and
cardiovascular diseases, independent of blood pressure, even with good hypertension control .

As Nepal is a developing country, the diagnosis of hypertensive retinopathy is made at very late
stage due to lack of health awareness and inadequate health facilities. Patient present at a very
late stage to hospital. Also due to socio-economic problems, they are non compliant to
medications resulting in poor blood pressure control. Limited studies have been conducted in the
governmental tertiary hospital. Thus, further studies are required in order to diagnose and
correlate hypertensive retinopathy.

This study will take place in Bir Hospital, a multidisciplinary tertiary center which will include
patients from all across Nepal. Most of the patients arriving in Bir Hospital are from diverse
socio-economic background and different places of Nepal. The sample population of which will
likely reflect the majority of Nepalese population residing across all 77 districts. Thus this study
will contribute to the epidemiology of Hypertensive retinopathy and its correlation with the
duration of hypertension and blood pressure control in the governmental tertiary hospital of
Nepal. It will also assist health policy planners to formulate and implement policies to increase
the health awareness and emphasize the need of incorporation of Hypertensive retinopathy
screening programmes in lower health instititutions for early diagnosis, timely referral and
treatment.
OBJECTIVES

GENERAL OBJECTIVES:
To study association of Hypertensive Retinopathy with control and duration of Hypertension
among non-diabetic hypertensive patient.

SPECIFIC OBJECTIVES:
1. To assess the prevalence of Hypertensive retinopathy in patient with Hypertension.
2. To correlate the severity of hypertensive retinopathy with duration since the diagnosis of
hypertension.
3. To correlate the severity of hypertensive retinopathy with control of hypertension.
4. To assess prevalence of other target organ damage(brain, kidney, heart) in patient with
hypertensive retinopathy.
METHODOLOGY

STUDY DESIGN:

Hospital based cross-sectional study

PLACE OF STUDY:

This study will be conducted in Department of Internal Medicine, Bir Hospital,NAMS,

Kathmandu, Nepal which is tertiary referral centre for people living all over Nepal with in time

frame of 1 year (probably from April 2020 to April 2021).

PERIOD OF STUDY:

10-14 months

STUDY POPULATION:

All patients visiting Internal Medicine Out Patient Department (OPD) and inpatients of medical

wards, Bir Hospital and fulfilling the inclusion criteria

SAMPLE SIZE

SAMPLE SIZE CALCULATION:

N=Z2PQ/D2

Z=standard normal deviate,usually set at 1.96 for confidence interval of 95%.

P=Prevalence of disease(27.3%) (24)

D=margin of error=10%

N=(1.96)^2*0.273*0.727/(0.10)^2=0.4978/0.01=76.24(77)
INCLUSION CRITERIA:

1. All patients with essential hypertension presenting to Internal Medicine OPD and

inpatients admitted in medical wards, Bir Hospital, Kathmandu.

EXCLUSION CRITERIAS:

1. Diabetic patients.

2. Patients with hazy ocular media.

3. Patients with history of laser photocoagulation.

4. Patients with shallow Anterior Chamber (AC).

5. Patients who have undergone intraocular surgeries like vitrectomy or retinal

detachment surgery.

6. Patients not giving consent.

7. Patients aged less than 20 years

8. Patient with history of use of retinotoxic drugs.

9. Patient with uncertain and incomplete information.

Data collection

 Recruitment
Cases will be recruited from hospital medical out patient department and inpatients admitted
in medical wards.

 Data Collection

Data collection will be started after getting letter of permission from the IRB, NAMS,
Hospital authority and respective unit chief. All the doctors nursing staff and other concerned
person will be informed about the study. Data will be collected using a structured proforma
prepared according to the objectives of study, covering the relevant details. Patients fulfilling
the inclusion criteria will be explained about the nature of the study and informed written
consent will be obtained from those willing to be enrolled. Data will be collected in a
structured questionnaire prepared according to objective of study. Data will be collected all
the days of weeks. Demographic details will be taken from the patient or patient party.
Duration of hypertension since diagnosis will be ascertained after detailed history and
reviewing medical records of patient if available. The Blood Pressure control status of the
patient will be primarily assessed by obtaining Blood pressure during office visit according
to standard protocol. Those with uncertain and incomplete information will be excluded from
the study. Routine mandatory blood investigations in hypertensive patient according to ISH 2020
guideline like CBC, Renal Function Test, Electrolytes, Liver Function Test, lipid profile, Random blood
sugar, Urinalysis, Uric acid level, ECG and Echocardiography will be carried out.

1. Vitals of the patient

2. Visual acuity by Snellen chart.

3. Fundus examination by a direct ophthalmoscope or slit lamp or fundal camera.

Tropicamide 1% and phenylephrine 2.5% combination will be used to dilate the pupil of the

patients with diabetes. After full dilatation of the pupil, fundus examination will be done and the

severity of hypertensive retinopathy will be graded according to the Keith and Wagner

classification system.

Measurements

Brachial blood pressure and pulse rate were measured using a validated battery powered

automated blood pressure machine with universal cuffs. Blood pressure and pulse rate

measurements were taken after a 15 minutes rest while the participant was seated. Three blood

pressure and pulse rate measurements were taken 3–5 min apart. The average of the last two

blood pressure readings were considered as the final reading for analysis.

Height (in cm) and weight (in Kg) were measured using a scale design with a height gauge .

Definitions

Hypertension: defined as either having a systolic blood pressure (SBP) equal to or greater than

140 mmHg and/or a diastolic blood pressure (DBP) equal to or greater than 90 mmHg and/or

self-report of previous diagnosis of hypertension by a health care provider and/or if currently

taking anti-hypertensives in the previous 2 weeks.

Awareness: defined as self-report of prior diagnosis by a health care provider among the

participants with hypertension.

Treatment of hypertension: defined as using pharmacologic blood lowering medicines at the time

of the interview among those aware of their hypertensive status.

Control of hypertension: defined as SBP below 140 mmHg and DBP below 90 mmHg while on

treatment among those on treatment.

Unhealthy intake of fats: defined as self-reported use of saturated fats e.g. lard, margarine, butter

and vegetable fat for cooking.

High salt consumption: defined self-report of far too much or too much consumption of actual

salt in processed foods, adding salt when cooking and/or to cooked food.

Tobacco use: defined as current use of smoked or smokeless tobacco.

The WHO Global Physical Activity Questionnaire was on used to collect information on

physical activity participation [25]. Insufficient physical activity was defined as self-reported less

than 150 min of moderate intensive activity or less than 75 min vigorous intensive physical

activity per week, including walking and cycling.

Body Mass Index (BMI): computed from the height and weight of the respondent - weight

divided by height squared (kg/m2). The BMI was further classified into four categories;

underweight if BMI was below 18.5 Kg/m2, normal if BMI is between 18.50 Kg/m2 and 24.99

Kg/m2, overweight if BMI is between 25 Kg/m2 and 29.99 Kg/m2 and obese if BMI is greater

than or equal to 30 Kg/m2.

Harmful use of alcohol: defined as consumption of more than 1 standard drink (which is the

amount of alcohol you find in a small beer, one glass of wine, or one tot of spirits) per day for

females and more than 2 standard drinks for males.

 Operational definition:

Hypertension:- diagnostic criteria for DM are fasting plasma glucose ≥126 mg/dL (7.0

mmol/L), 2-hour plasma glucose ≥200mg/dL (≥ 11.1mmol/L) or glycated

hemoglobinA1C (HbA1C) ≥ 6.5%

KEITH AND WAGNER CLASSIFICATION OF HYPERTENSION

Non-ProliferativeDiabetic
Retinopathy
Grade 0 No abnormalities

Grade 1 Slight constriction of retinal arterioles

Grade 2  Slight constriction of retinal arterioles + focal narrowing of retinal

arterioles + AV nicking
Grade 3

 Severe retinal hemorrhages- about 20 medium-large per

quadrant-in 1-3 quadrants or mild IRMA
 Significant venous beading in no more than 1 quadrant
 Cotton wool spots

The blood pressure control of the hypertensive will be assessed by measuring Blood pressure in

office using standard protocol , at least 3 reading will be taken and average of last two reading is

taken as blood pressure of patient:-

BP CONTROL BLOOD PRESSURE

CONTROLLED <140/90

UNCONTROLLED >140/90

Duration of hypertension of the subjects will be assessed by taking a detailed medical history and

reviewing their medical records. Based on the duration of hypertension, they will be classified as

below:

Groups Duration of Hypertension

Group A <10 years

Group B 10-20 years

Group C 20-30 years

Group D >30 years

 Conduct of the study

Patients from hospital medical OPD and inpatients of medical wards of Bir Hospital with
age of 20 or above age group will be evaluated and enrolled after taking the informed
consent. Confidentiality will be maintained.

DATA ANALYSIS AND STATISTICAL ANALYSIS

The data will be entering into Excel spreadsheet. Coding of data will be done and errors will be
checked. Clean data will be transfer to SPSSv20 for further statistical analyses. Statistical
package for social science (SPSSv20) software will be used for the analysis of entered data. Data
will be present on frequency, percentage and table. Chi-square test will be used to observe the
association of dependent and independent categorical variables and independent t-test will be
used for continuous variables. The p- value <0.05 will be considered statistically significant
DUMMY TABLES:

Table 1: Demographic information of patient

No. of Cases Percentage

Sex
Male

Female

Age Group (Years)

20 -40

41-60

61-80

>80

BMI
<=21

>21

Hypertension
Yes

No

Smoking habit
Yes

No

Alcohol consumption
Yes

No
Table 2.Group distribution of cases based on severity of diabetic retinopathy and
correlation with duration of diabetes mellitus.

Group GRADE 1
GRADE 2 GRADE 3 GRADE 4
Distribution
NO. % NO. % NO. % NO. %

Duration Of Hypertension NO. % NO. % NO. % NO. %

(Years)

< 10 years (Group A)

10-20 years (Group B)

21-30 years (Group C)

> 30 years (Group D)

Table 3.Correlation of severity of retinopathy and control

Hba1c GRADE I GRADE II GRADE III GRADE IV

No. % No. % No. % No. %

Optimal control
(BP <140/90)
Uncontrolled
(BP>140/90)

ETHICAL CONSIDERATION

An approval for the study will be obtained from institutional review board ethics committee.
Before including the patient in study, all patients will be well informed and both written and
verbal consent will be taken. All patients will be thoroughly examined. Patients will have the
right to refuse to be involved in the study after all the information. Complications if any during
the study period will be managed as per the standard hospital protocol.

This study will not require any complicated intervention, other than routine investigation and slit
lamp biomicroscopic examination. Strict confidentiality shall be maintained and the identity of
the patient will not be disclosed under any circumstances without his/her permission and any
piece of information including pictures, videos or information will not be published without
his/her written consent. The information shall be used solely for academic purpose without
affecting the physical, mental or social health of the patient. The patients will not be given any
extra financial burden and will have the right to withdraw from the study at any point of time if
he/she wishes.
GANTT CHART
Tentative duration: 1 year after IRB approval
The study will be carried out over the period of three months after approval from IRB, NAMS.
The data will be analyzed over the period of next three months. The final thesis will be written
over a period of three months and submitted six months before the final exam.

Activities 2020 2021

S. Oct Nov Dec Ja Feb Ma Apr Ma Jun Jul Au Sep

N. n r y e y g t

1 Problem
identification

2 Literature review

3 Topic Selection

4 Writing Thesis
Proposal

5 Review Thesis
Proposal

Submission to
IRB
7 Approval from
IRB

8 Data collection

9 Data Analysis

10 Final thesis
writing

11 Final correction
and submission

BUDGET

The budget of the study will be as follows:

Heading of expenses Amount (NRs)

Books and Journal 6000

Stationery and report writing 5000

Statistician consultation 10000

Internet 2500

Miscellaneous 4000

Grand Total 27,500

ANNEX 1: INFORMED CONSENT FORM

I /On behalf of my relative ………………………………………. am willingly

participating in the study titled “ Hypertensive retinopathy and its relation to duration and
control of hypertension among non-diabetic hypertensive patient ” being conducted in
National Academy of Medical Sciences, Bir Hospital. I have been fully explained about the
details of the study and procedures. I have been assured that confidentiality will be maintained to
the utmost and no names, documents or results will be disclosed or circulated anywhere other
than the hospital doctors or research guide and co-guide. I am also aware that I have full rights to
withdraw my participation from this study whenever I wish to do so. My treatment will not be
compromised even if I withdraw myself from the study. The cost of the lab will be borne by the
researcher himself. I will neither be charged extra costs nor be paid any extra benefits regarding
this study.
Researcher Participant/Guardian

Signature: Signature:
Name: Dr. Bikal Lamichhane Name:

(MD Resident, Internal Medicine, NAMS) Relation with patient:

Date: Address:

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ANNEX 2: मंजुरिनामा

म/मे रो .................................................................. लाई यस“Hypertensive retinopathy and its relation

to duration and control of hypertension among non-diabetic hypertensive patient ”नामको
अनु सन्धानात्मक अध्ययनमा सं लघ्न गराईएको कुरा मलाई जानकारी छ।उक्त अध्ययनको बारे मा मै ले राम्रोसं ग
बु झेको छु र यसमा भाग लिन म राजीखु शी छु। अध्ययनको प्रकृति तथा अध्ययनको क् रममा यसका सम्भावित
जोखिमहरूको बारे मा मलाई डा. बिकल लामिछाने ले जानकारी गराउनु भएको छ।

यस अध्ययनबाट ईच्छा नलागेको खण्डमा कु नै पनि बेला बाहिरिन सकिने कु रा पनि मलाई जानकारी गराईएको छ।

बिरामीपक्ष

नाम:

सम्बन्ध: अनुसन्धानकर्ताकोसही:

सही: अनुसन्धानकर्ताकोनाम: डा. बिकल लामिछाने

मिति:
PERFORMA

A. Patient Particular:-

Serial Number.:Hospital/ Inpatient Number: Date: 207 / /

Name:
Age: years
Gender: Male/ Female

Address:
Contact No.:
Occupation:

Education: Height: Weight:

BMI: Smoking habit: Alcohol consumption:

B..Diagnosis:-
C. Other Factors:-

HTN- Yes/ No SBP: DBP Duration of diabetes :

D. Laboratory information:-

Fasting Blood Sugar(FBS)

Post Prandial Blood Sugar(PPBS)

HbA1C

Serum Uric acid

Serum Lipid profile

1. Hypertension. https://www.who.int/news-room/fact-sheets/detail/hypertension.

2. Improving hypertension control in 3 million people: country experiences of programme

development and implementation. https://www.who.int/publications/i/item/improving-
hypertension-control-in-3-million-people-country-experiences-of-programme-development-and-
implementation.

3. Unger, T. et al. 2020 International Society of Hypertension Global Hypertension Practice

Guidelines. 24.
4. Aryal, K. K. et al. The Burden and Determinants of Non Communicable Diseases Risk
Factors in Nepal: Findings from a Nationwide STEPS Survey. PLOS ONE 10, e0134834 (2015).

5. Huang, Y. et al. Prevalence of hypertension and prehypertension in Nepal: a systematic

review and meta-analysis. Glob. Health Res. Policy 4, 11 (2019).

6. Mensah, G. A., Croft, J. B. & Giles, W. H. The heart, kidney, and brain as target organs
in hypertension. Cardiol. Clin. 20, 225–247 (2002).

7. Gupta, R., Gupta, S., Sukharamwala, D., Vashi, J. & Gahlot, A. Evaluation of
hypertensive retinopathy in patients of essential hypertension with high serum lipids. Med. J. Dr
Patil Univ. 6, 165 (2013).

8. Ray, S., Sahu, B. K. & Naskar, S. Hypertensive retinal changes: It’s prevalence and
associations with other target organ damage. Indian J. Med. Sci. 72, 195–200 (2020).

9. Thapa et al. - 2017 - Prevalence, pattern and risk factors of retinal ve.pdf.

10. Pun, C. & Tuladhar, S. Profile of Hypertensive Retinopathy in a Tertiary Centre in

Western Nepal. J. Gandaki Med. Coll.-Nepal 12, 22–24 (2019).

11. Godar, S. T. & Kaini, K. R. Prevalence and Risk Factors of Hypertensive Retinopathy in
Hypertensive Patients in a Tertiary Hospital of Gandaki Province of Nepal. 8, 5 (2020).

12. Karki, K. J. Incidence of ophthalmoscopic fundus changes in hypertensive patients.

Kathmandu Univ. Med. J. KUMJ 1, 27–31 (2003).

13. Shrestha, A. P., Poudel, M. & Rai, B. K. PS 17-59 SUBCLINICAL TARGET ORGAN
DAMAGE IN HYPERTENSIVE PATIENTS AT A TEACHING HOSPITAL IN EASTERN
NEPAL. J. Hypertens. 34, e490 (2016).