Clinical Research Proposal: Diabetic Retinopathy Impact and Treatment

This clinical research proposal investigates diabetic retinopathy, a disease affecting the retina in diabetic patients. The proposal examines the impact of diabetic retinopathy on patient health within six months, exploring the causes and contributing factors, including high blood glucose levels and pre-existing eye conditions. It also explores the two effective methods for diagnosing and treating the condition, such as pupil dilation, fluorescein angiogram, Anti-VEGF injection therapy, and scatter laser surgery. The study employs quantitative research methods, including questionnaires and surveys, to gather data from service users, alongside ethical and legal considerations. The proposal includes detailed aims, objectives, research questions, hypotheses, data analysis methods, and resource allocation, with the aim of analyzing the causes, factors, and effective treatments for diabetic retinopathy. The study uses both primary and secondary sources to collect data and information. The proposal uses Gantt charts to show interrelation between activities. The data analysis involves the use of R programming.

Clinical
Research Proposal
2_1582550386 (2)

Table of Contents
ABSTRACT.....................................................................................................................................1
INTRODUCTION...........................................................................................................................1
The impact of diabetic retinopathy on health of patient within 6 months..................................1
The 5 causes and factors contributing to the occurrence of diabetic retinopathy.......................1
The 2 effective ways of diagnosing and treating diabetic retinopathy........................................2
RESEARCH QUESTION/HYPOTHESIS, ....................................................................................2
METHODS......................................................................................................................................3
Resources....................................................................................................................................3
Sampling.....................................................................................................................................3
Time course100...........................................................................................................................4
Ethical and legal considerations..................................................................................................6
DATA PROCESSING AND ANALYSIS......................................................................................6
Data analysis...............................................................................................................................7
IMPLICATIONS FOR THE STUDY...........................................................................................12
CONCLUSION .............................................................................................................................13
REFERENCES..............................................................................................................................14

ABSTRACT
The diabetic retinopathy is defining as a types of disease from which it can infected to
retina of eyes. In this disease, blood vessels get swells, blood leakage occur and some other sighs
occur. There are various other symptoms occur from this disease such as blurred vision, loss of
vision and dark vision. As there are various complication occur with this problem as improper
development of blood vessels occur in this. Under this report, the impact of diabetic retinopathy
is covered as it has various impact on health condition of a human. The obesity, kidney problems
and other occurs at starting stage of occurrence of this disease. There are various factors which
helps in occurrence of disease in eye of human. The untreated of this disease can also cause
various problem in eyes as person can become fully blind. There are some cause which
contribute in occurrence of this disease such as presence high level of blood glucose in human
body. It also includes the presence of other previous eyes cataracts which enhance eyes
contraction and makes the person blind and blurred. There are various ways from which diabetic
retinopathy can be treated.
BACKGROUND
The clinical research proposal is necessary to conduct as it provides relevant information
about any study. As the more relevant studies are published which help in assisting researcher in
identifying cause of it. This is necessary to be undertake by researcher from which they can
influence their information properly. The most appropriate studies are mainly published on a
specific subject. That help in assisting researcher in their subject. With this the researcher can
analyse appropriate information about any topic. This also help in deliver services according to
relevant information. As the evidence based practices is an appropriate manner of providing
services to people.
INTRODUCTION
The diabetic retinopathy is a common type of disease that occur due to changes in blood
vessels (Portney, 2020). This is occurring in retina of eye which is present in back of eye that
help in changing light into images. In this condition, swelling of blood vessels, leakage of blood

and other symptoms occur (Pencina, 2016). If this disease left undiagnosed then it can damage
retina. It generally occurs in diabetic patients who has type 2 diabetes1.
The impact of diabetic retinopathy on health of patient within 6 months.
According to the views of Fenwick (2020), the various impact of diabetic retinopathy
occurs on health of patient. The new blood vessels in eyes are does not grow properly(Irwin,
2019). It also includes flow of bleeding which impacted on retina which cause casual loss of
irreversible vision (Taylor, 2017). The hypertension, obesity and kidney problems are some
other conditions which impacted on health patient along with eye problem (Fenwick, 2020). If
this disease left untreated then it can cause permanent loss of vision which is refer to as Macular
Oedema2.
The 5 causes and factors contributing to the occurrence of diabetic retinopathy
According to the views of Lima (2020), there are some causes which contribute in
occurrence of diabetic retinopathy (Fain, 2017). The cause of behind this disease occur such as
glaucoma, macular degeneration, refractive error, cataracts and level of high blood glucose
which enhance loss of vision and blindness3. These all causes deterioration of retina with
different conditions that result in blurred vision of eye (Patten, 2016). The factors are depending
on manner of cause and process of diabetic retinopathy (Ambe, 2016). The factors which
contribute in occurrence of this disease are such as duration of disease, age, hyperglycaemia,
inflammation and genetic factors4.
1 Cai X, McGinnis JF. Diabetic retinopathy: animal models, therapies, and perspectives.
Journal of diabetes research. 2016;2016.
2 Avogaro A, Fadini GP. The effects of dipeptidyl peptidase-4 inhibition on
microvascular diabetes complications. Diabetes care. 2014 Oct 1;37(10):2884-94.
3 Chae JB, Joe SG, Yang SJ, Lee JY, Sung KR, Kim JY, Kim JG, Yoon YH. Effect of
combined cataract surgery and ranibizumab injection in postoperative macular edema in
nonproliferative diabetic retinopathy. Retina. 2014 Jan 1;34(1):149-56.
He BB, Wei L, Gu YJ, Han JF, Li M, Liu YX, Bao YQ, Jia WP. Factors associated with
diabetic retinopathy in chinese patients with type 2 diabetes mellitus. International
journal of endocrinology. 2012;2012.
4 Burgansky-Eliash Z, Barak A, Barash H, Nelson DA, Pupko O, Lowenstein A,
Grinvald A, Rubinstein A. Increased retinal blood flow velocity in patients with early
diabetes mellitus. Retina. 2012 Jan 1;32(1):112-9.

The 2 effective ways of diagnosing and treating diabetic retinopathy
According to the views of Lee (2020), the diagnoses of diabetic retinopathy can be
occurring by examining through doctors (Mauro, 2017). This can be developing by two ways
methods which are pupil dilation and fluorescein angiogram (Boxberg, 2017). The treatment is
based on type of diabetic retinopathy disease that are present in body (Khalilzadeh, 2017). It
includes Anti-VEGF injection therapy and scatter laser surgery5.
RESEARCH QUESTION/HYPOTHESIS,
AIMS & OBJECTIVES
Aim: To analyse the cause of diabetic retinopathy and factors contributing for occurrence
of this situation.
Objectives
 To evaluate the 5 causes and factors contributing to the occurrence of diabetic
retinopathy.
 To explore the impact of diabetic retinopathy on health of patient within 6 months.
 To analyse the 2 effective ways of diagnosing and treating diabetic retinopathy.
Questions
 What are the 5 causes and factors contributing to the occurrence of diabetic retinopathy?
 How to examine the impact of diabetic retinopathy on health of patient within 6 months?
 How to analyse the 2 effective ways of diagnosing and treating diabetic retinopathy?
Hypothesis 1:
 Null hypothesis: μ = There is some causes and factors that plays essential role in
contributing for the occurrence of diabetic retinopathy.
5 He BB, Wei L, Gu YJ, Han JF, Li M, Liu YX, Bao YQ, Jia WP. Factors associated
with diabetic retinopathy in chinese patients with type 2 diabetes mellitus. International
journal of endocrinology. 2012;2012.
Ip MS, Domalpally A, Hopkins JJ, Wong P, Ehrlich JS. Long-term effects of
ranibizumab on diabetic retinopathy severity and progression. Archives of
ophthalmology. 2012 Sep 1;130(9):1145-52.
Kaštelan S, Tomić M, Gverović Antunica A, Salopek Rabatić J, Ljubić S. Inflammation
and pharmacological treatment in diabetic retinopathy. Mediators of Inflammation.
2013;2013.

 Alternative hypothesis: μ ≠ There is some causes and factors that plays essential role in
contributing for the occurrence of diabetic retinopathy.
Hypothesis 1:
 Null hypothesis: μ = There is the impact of diabetic retinopathy on health of patient. Alternative hypothesis: μ ≠ There is the impact of diabetic retinopathy on health of
patient.
Hypothesis 3:
 Null hypothesis: μ = There are different effective ways of diagnosing and treating
diabetic retinopathy.
 Alternative hypothesis: μ ≠ There are different effective ways of diagnosing and treating
diabetic retinopathy.
METHODS
The quantitative research is used to collecting information by investigating from service
users by using method of sampling. The researcher collect data by conducting questionnaire and
surveys. It is used to identify issues with help of numerical data that can turned into statistics.
This is an emphasised by use of communication with population that includes questions which
state about behaviour and perception of people. With this research, the data can be collected by
using graphs in a rank order. The data are collected from interviews, clinical trials and close
questions. The qualitative method is used to identify data with the help of observation in order to
get non numerical information. It includes symbols, definitions and description of any thing. It
involves documents, questionnaires, interviews that help in gathering information. In this
proposal, quantitative method is used for research along with primary and secondary sources to
collect data and information.
Resources
The resources are referring to origin of collecting information from which the research
has been conducted. There are two types of resources which are described below.
Primary sources: - the information is collected from interviews, observation, surveys
and questionnaire, etc. the data can be collected from first handed by researcher to conduct any

inquiry. This can be conduct on a special time period in which they collect data about any
information. It represents original thinking of respondents6.
Secondary sources: - in this research, data is collected from another person analysis. The
secondary resources can be collected through journals, books and other ways that are already
conducted. It describes the identification, analyse and evaluation of primary resources. This can
be occurring through verbally or non-verbally by written or non-written methods7.
Sampling
The sampling refers to procedure of examining data in which it planned. It includes
amount of sample that are taken to analyse from bigger population of service providers. This
depends on type of analyse that are used for identifying larger population. It includes random
sampling method.
Random sampling: - It is the manner of sample which is collected for observation. In
this technique each sample is chosen as equal probability. This technique is occurring from
unbiased cooperation with respondents. In this members are selected randomly and it helps in
making general for large member of population. The sample size is used in this is for 40
respondents8.
Ethical and legal considerations
The Ethical principles is one of the most important part of research. It is necessary to be
conduct at time of research as it assist in maintaining dignity of respondents appropriately. The
respondents should not be accessible to any injury in a every aspects. It is important to hold
respect of respondents. The confidentiality of principles is occurring in central system of medical
in which personal health of patients are maintain including their private information. This cannot
be disclosed without their permission. The legal principles are also necessary to consider as it
6 Fowler Jr FJ. Survey research methods. Sage publications; 2013 Sep 18.
7 Zikmund WG, Carr JC, Griffin M. Business Research Methods (Book Only). Cengage
Learning; 2013 Jun 25.
8 Moring B. Research methods in psychology: Evaluating a world of information. WW
Norton & Company; 2014 Jun 10.

helps in describing laws which are for respondents. So that they dos not receive harm from any
researcher.
Time course
Gantt chart: this is a graph representation which stated or show interrelation between all
activities. It assists in facilitate various information that are linked with task which are necessary
to be completed in time. The project manager can be providing outline of activities that are
performing. This help in completion of activities or project on time as the task can be occur
properly.

DATA PROCESSING AND ANALYSIS
The data analysis can be used to identify data from various sources and information.
From different sources, it has been gathered and reviewed which help in analysing data with sort
of findings. In this, R programming is used for analysis of data. This programme is mainly used
to analyse data and statistics from appropriate source. With help of this, data is effectively
gathered and secured in a confidentially place which does not disclose to anyone.
Questionnaire
Q1. Do you know about disease of diabetic retinopathy? Yes No
Q2. What are the factors that cause diabetic retinopathy? Duration of disease Age Hyperglycaemia
Q3. What prevention method are attaining by people to prevent from diabetic retinopathy? Healthy lifestyle Regular screening Prevention from substance use
Q4. How the percentage of diabetic retinopathy cause among people with this disease? Mild nonproliferative retinopathy Moderate nonproliferative retinopathy Severe nonproliferative retinopathy
Q5. What are the benefits of diagnosing of diabetic retinopathy? Reduce complications
 Easy overcome

Data analysis
Theme 1: The knowledge about disease of diabetic retinopathy?
Q1. Do you know about disease of diabetic retinopathy? Frequency Yes 20 No 20
20 20 Yes
No
Interpretation: - From above graph, this has been interpreted that approx. 20 respondents
who are associated with medical know about disease that occur from their diabetes. While 20
respondents do not know about 20 respondents as they do know that diabetes can also cause
retinopathy which is a disease of an eye.
Theme 2: - The factors that cause diabetic retinopathy.
Q2. What are the factors that cause diabetic retinopathy? Frequency Duration of disease 15 Age 15 Hyperglycaemia 10

Interpretation: - the give graph represented that, there are number of factors are available
that cause diabetic retinopathy. The 15 respondents believe that it highly causes from duration of
disease as most of people does not take prevention form it. The other 15 respondents refer that
age factor mostly causes this disease as older age of people does not receive appropriate care in
their disease.
Theme 3: - The prevention method is attaining by people to prevent from diabetic retinopathy.
Q3. What prevention method are attain by people to prevent from diabetic
retinopathy?
Frequency
 Healthy lifestyle 12 Regular screening 18 Prevention from substance use 10
15
15
10
Duration of disease
Age
Hyperglycaemia

Interpretation: - the above given graph represented that there is some prevention method
that are acquired by patients. The 12 respondents believe that patients are maintaining their
health lifestyle which prevent them from this disease. The other 18 respondents believe that there
are some patients who perform regular screening of their body which help them to analyse about
prevention. The 10 respondents stated that there are some people who take prevention from
substance use.
Theme 4: - The percentage of diabetic retinopathy cause among people with this disease.
Q4. How the percentage of diabetic retinopathy cause among people with
this disease?
Frequency
 Mild nonproliferative retinopathy 14 Moderate nonproliferative retinopathy 7 Severe nonproliferative retinopathy 19
12
18
10
Healthy lifestyle
Regular screening
Prevention from
substance use

Interpretation: - the given graphical represent that, 14 respondents believes that some of
the people have mild nonproliferative retinopathy. While 7 respondents refer as the other people
have moderate nonproliferative retinopathy. The 19 respondents believe that there are people
who has severe nonproliferative retinopathy.
Theme 5: - The benefits of diagnosing of diabetic retinopathy.
Q5. What are the benefits of diagnosing of diabetic retinopathy? Frequency Reduce complications 25 Easy overcome 15
14
7
19
Mild nonproliferative
retinopathy
Moderate
nonproliferative
retinopathy
Severe
nonproliferative
retinopathy
25
15
Reduce complications
Easy overcome

Interpretation: -from the above graph, it has been represented that the 25 respondents
refers that the diagnosing of diabetic retinopathy can reduce complication of it. While the other
15 have a belief is that with diagnoses can easily overcome from this disease.
IMPLICATIONS FOR THE STUDY
The long term goal can be implicated with this project as it helps researcher in their
clinical practices. From this, they can develop understanding about effectiveness of diabetic
retinopathy among patients. It also assists them to motivate and enhance people to take effective
steps in their health and wellbeing. This project helps public health from which they can take
effective prevention by identifying cause and impact of disease. As this project briefly explain
about impact of this disease. It also helps in future as from this people can aware about use of
substances which are need to be prevented.

CONCLUSION
From the above report, it has been concluded that there is various impact of diabetic
retinopathy occur on health of human. There are numerous cause and factors are present through
diabetic retinopathy which contribute in occurrence of this disease. The effective ways can help
patients in diagnosing with this disease.

REFERENCES
Books and journals
Ambe, P.C., Papadakis, M. and Zirngibl, H., 2016. A proposal for a preoperative clinical scoring
system for acute cholecystitis. Journal of Surgical Research, 200(2), pp.473-479.
Avogaro A, Fadini GP. The effects of dipeptidyl peptidase-4 inhibition on microvascular
diabetes complications. Diabetes care. 2014 Oct 1;37(10):2884-94.
Boxberg, M., and et. al., 2017. Tumour budding activity and cell nest size determine patient
outcome in oral squamous cell carcinoma: proposal for an adjusted grading
system. Histopathology. 70(7). pp.1125-1137.
Burgansky-Eliash Z, Barak A, Barash H, Nelson DA, Pupko O, Lowenstein A, Grinvald A,
Rubinstein A. Increased retinal blood flow velocity in patients with early diabetes
mellitus. Retina. 2012 Jan 1;32(1):112-9.
Cai X, McGinnis JF. Diabetic retinopathy: animal models, therapies, and perspectives. Journal of
diabetes research. 2016;2016.
Chae JB, Joe SG, Yang SJ, Lee JY, Sung KR, Kim JY, Kim JG, Yoon YH. Effect of combined
cataract surgery and ranibizumab injection in postoperative macular edema in
nonproliferative diabetic retinopathy. Retina. 2014 Jan 1;34(1):149-56.
Fain, J.A., 2017. Reading, understanding, and applying nursing research. FA Davis.
Fowler Jr FJ. Survey research methods. Sage publications; 2013 Sep 18.
He BB, Wei L, Gu YJ, Han JF, Li M, Liu YX, Bao YQ, Jia WP. Factors associated with diabetic
retinopathy in chinese patients with type 2 diabetes mellitus. International journal of
endocrinology. 2012;2012.
Ip MS, Domalpally A, Hopkins JJ, Wong P, Ehrlich JS. Long-term effects of ranibizumab on
diabetic retinopathy severity and progression. Archives of ophthalmology. 2012 Sep
1;130(9):1145-52.
Irwin, D.L., Lass, N.J., Pannbacker, M., Koay, M.E.T. and Whited, J.S., 2019. Clinical research
methods in speech-language pathology and audiology. Plural Publishing.
Kaštelan S, Tomić M, Gverović Antunica A, Salopek Rabatić J, Ljubić S. Inflammation and
pharmacological treatment in diabetic retinopathy. Mediators of Inflammation.
2013;2013.
Khalilzadeh, O., and et. al., 2017. Proposal of a new adverse event classification by the society
of interventional radiology standards of practice committee. Journal of Vascular and
Interventional Radiology, 28(10), pp.1432-1437.
Mauro, C., and et. al., 2017. Performance characteristics and clinical utility of diagnostic criteria
proposals in bereaved treatment-seeking patients. Psychological medicine, 47(4),
pp.608-615.
Moring B. Research methods in psychology: Evaluating a world of information. WW Norton &
Company; 2014 Jun 10.

Patten, M.L., 2016. Proposing empirical research: A guide to the fundamentals. Routledge.
Pencina, M.J., and et. al., 2016. Supporting open access to clinical trial data for researchers: the
Duke Clinical Research Institute–Bristol-Myers Squibb Supporting Open Access to
Researchers Initiative. American heart journal, 172, pp.64-69.
Portney, L.G., 2020. Foundations of Clinical Research: Applications to Evidence-Based
Practice. FA Davis.
Taylor, R.R., 2017. Kielhofner's research in occupational therapy: Methods of inquiry for
enhancing practice. FA Davis.
Zikmund WG, Carr JC, Griffin M. Business Research Methods (Book Only). Cengage Learning;
2013 Jun 25.
Online
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[Online]. Available through:<https://bjo.bmj.com/content/95/6/774>
Lima C. V., 2020. Risk factors for diabetic retinopathy: a case–control study [Online]. Available
though: <https://journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-
016-0047-6>
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<https://www.aaojournal.org/article/S0161-6420(93)31449-1/fulltext>