Appendix B

Analysis Plan/Application data/materials

Analysis plan #:

Date received:

Date approval:

To be filled in by The
Maastricht Study.

1. Title
Diabetes type 2 and risk of glaucoma .

2. First author
Name:
3. Co-authors
Informed co-owner(s): Yes
Name(s) co-owner(s) that were
informed:
J. schouten .

Provide list of co-owner(s) who agreed to be

co-author: Click here to enter text.

Are you a student and will this work be part of your bachelor/master thesis
Yes*
If yes, please provide details about your program:
This is part SCIP program of my last year in medical school. this is 18 weeks program that I have to follow
the research of my supervisor, collect the data, analyze the data and then finally making the final theses and
needed to be evaluated by the supervisor doctor.

* Please send your final thesis to the MT of the Maastricht Study via

4. Research questions and hypotheses

Is glaucoma more prevalent in DM-2 compared to individuals without DM-2?

What is the impact of diabetes duration over the risk of glaucoma development?
Is there any difference between the visual field defect of glaucoma for the diabetic and non-diabetic patients?
In this study we propose multiple hypotheses. The duration of diabetes has no connection with glaucoma
severity. Moreover, the pathology of glaucoma in diabetic and non-diabetic patients will be different because
both are diverse conditions
5. Background
Background and rationale for addressing the research questions and
hypotheses.
Diabetes has been linked with various co-morbidities. Glaucoma is one of the
foremost causes of irreversible blindness across the globe (Zhao et al. 72-78). It is
found that the microvascular damage occurred in glaucoma is an impact of T2DM in
that person that further impacts the vascular regulation of optic and retina nerve.
Diabetes also has been found involved in increased intraocular pressure (IOP) (Tan et
al. 1354-1361).also has been found involved in increased intraocular pressure (IOP)
(Tan et al. 1354-1361). Thus, it is necessary to understand the relation of T2DM and
glaucoma so that it can be controlled from developing in diabetic patients. According to
the literature, this association has been very prominent and it has been verified that
diabetic patients are more prone of developing glaucoma in comparison of non-diabetic
patients (Pasquale et al. 1081-1086). A meta-analysis conducted by Zhou and coresearchers analyzed 13 different studied to determine the connection between primary
open-angle glaucoma (POAG) and diabetes mellitus (DM). Among these 13 studies six
were case-control studies while seven were population-cohort studies which led to the
conclusion that the diabetic patients are highly susceptible of developing open-angle
glaucoma in comparison of non-diabetic patients (Zhou et al.). Another study that aimed
to investigate the relation also focused to discover whether the diabetic control and the
length of the disease impacts this evident relation. On the basis of extracted finding, the
research concluded that regardless of any factor there is a strong connection between
2

both of the condition (Halilovic et al.). Based on a Los Angeles Latino Eye Study it is
concluded that T2DM and open-angle glaucoma (OAG) together is the fastest growing
problem (Chopra et al. 227-232; Shen et al. 147-155) .This cohort study has as its aims
to discover whether the visual field defect found in glaucoma patients is different
between individuals that are diabetic and non-diabetic. The growing incidence T2DM
patients has been a serious issue and to treat and prevent glaucoma as a cause of
blindness in DM-2 it is important to understand this connection of diabetes and
glaucoma. It will facilitate to understand the progression course of glaucoma, its
treatment, and developing preventable measures that will lower the onset of glaucoma
among diabetes patients as well as its progression and symptom severity. Furthermore,
it is also necessary to detect whether the disease duration and presence of glycemic
control can impact the glaucoma progression. The visual field defect in Glaucoma
might be different in diabetic and non-diabetic conditions. This study will produce
significant implications for developing effective preventive and screening measures for
diabetic patients.

6. Design and sample

Study design and main in- and exclusion criteria of the study sample, e.g. crosssectional study in participants with type 2 diabetes.

The study will include approximately 3200 participants, out of which 1000 patients with diabetic type 2
(T2DM) and rest are healthy individuals.
Inclusion criteria
The inclusion criteria for the subject selection includes the patients aged 45 years and above. Participants of
the Maastricht study will be included.

Exclusion criteria:
The exclusion criteria of the subject selection in this study are based the absence of a visual field or IOP
measurement.

Methods:
Study design: cross-sectional study
Method of selection:
Only those subjects were included in the study who met inclusion criteria whereas rests of the subjects were
excluded.

7. Variables
3

All requested variables should be identified. Please list the variable names from the
code books of The Maastricht Study.

Variable Name

General Description

"Co-owner(s)"

Main independent variable(s) Optical Coherence Tomography

Outcome variable(s)

Confounders

around the optic

nerve
Tomography
around
thehead
optic
nerve
head
Heidelberg Edge Perimetry
non-contact tonometry
Glucose metabolism
status+(OGTT
+
OGTT
medication
history)
diabetic complications (
Age , HbA1c, diabetes
duration
, medication history,
family
history
History
, Physical
activity
, Alcohol ,
Alcohol
, smoking

8. Statistical analyses
Briefly describe the statistical
analyses.

The data will be analyzed using spss software for statistical analysis. Cross-tabs will be used and the Chisquare test for statistical significance
9. Mock Tables
Include mock-up of key
tables.

Table 1. Characteristics of the Study Population

healthy Individuals (%) or

mean SD

Individuals with type 2

diabetes (%) or mean
SD

Age (y)
Diabetes duration (y)
Race
BMI
Smoking
Yes
No
HbA1C (%)
Table 3. Diagnostic analysis of ocular variables.
.

Diagnostic Analysis
Sensitivit
y

Specificity

Positive
Predictive Value

Negative
Predictive Value

Area-UnderCurve
(Accuracy)

Optical Coherence Tomography around the

optic nerve head
Heidelberg Edge Perimetry
non-contact tonometry
corneal thickness

10. Timeline
A timeline for completion and submission of the
paper.

References :
Chopra, Vikas, et al. "Type 2 diabetes mellitus and the risk of open-angle glaucoma: the
Los Angeles Latino Eye Study." Ophthalmology 115.2 (2008): 227-232.
5

Diagnosti
Rati

Halilovic, Emina Alimanovic, et al. "Analysis of the Influence of Type of Diabetes

Mellitus on the Development and Type of Glaucoma." Medical Archives 69.1
(2015): 34.
Pasquale, Louis R., et al. "Prospective study of type 2 diabetes mellitus and risk of
primary open-angle glaucoma in women." Ophthalmology 113.7 (2006): 10811086.
Shen, Ling, et al. "Diabetes Pathology and Risk of Primary Open-Angle Glaucoma:
Evaluating Causal Mechanisms by Using Genetic Information." American journal
of epidemiology 183.2 (2016): 147-155.
Tan, Gavin S., et al. "Diabetes, metabolic abnormalities, and glaucoma: the Singapore
Malay Eye Study." Archives of Ophthalmology 127.10 (2009): 1354-1361.
Zhao, Di, et al. "Diabetes, fasting glucose, and the risk of glaucoma: a meta-analysis."
Ophthalmology 122.1 (2015): 72-78.
Zhou, Minwen, et al. "Diabetes mellitus as a risk factor for open-angle glaucoma: a
systematic review and meta-analysis." PLoS One 9.8 (2014): e102972.