| INFORMATION ABOUT THE STUDY
St Paul’s Eye
Unit
Royal Liverpool University Hospital
Prescot St
Liverpool
L7 8XP
Tel: +44 (0)151 706 3973
Fax: +44 (0)151 706 5436
The research project is now complete and the CE mark has not yet been obtained. It should also state that we accept no liability for the usage of this test.
10 June 2002
Study Ref: 01/231
1. MULTIFIXATION CAMPIMETRY
FOR INTERNET:
Helping patients discover hidden blind-spots in their own field of vision
2. Invitation
You are being invited to take part in a research
study. Before you decide it is important for you to understand why the
research is being done and what it will involve. Please take time to read
the following information carefully and discuss it with friends, relatives
and your GP if you wish. Take time to decide whether or not you wish to
take part.
Thank you for reading this.
3. What is the purpose
of the study?
We have developed a test to enable you to detect
any hidden blind-spots in your own visual field by playing a ‘cat-and-mouse’
type of computer game, to be made available over the internet free of
charge. Now we need to find out how well the test works, by examining
patients with known visual field defects and healthy individuals.
4. Why have I been
chosen?
You have either selected yourself or you have been
chosen because you have a condition known to cause visual field loss.
We expect to include several hundred patients in our study.
5. Do I have to take
part?
If we have invited you to participate, it is up
to you to decide whether or not to take part. If you do decide to take
part you can print this information sheet to keep. You will also need
to click on the button below to indicate you have read and understood
the instructions. If you decide to take part you are still free to withdraw
at any time and without giving a reason. If you are a patient at our hospital,
this will not affect the standard of care you receive from us.
6. What will happen
to me if I take part?
If you agree to take part, you will perform a visual
field test using your own computer in your own home and in your own time.
You will then be invited to email the results to us together with some
information on yourself. We would expect the test to take between ten
and twenty minutes.
We will show any results you send us to an eye specialist who is not aware
of your condition so that he or she will decide whether or not they are
abnormal. We will also compare your results with those of other volunteers
so that we can develop our test further.
7. What do I have
to do?
You will need to perform visual field examination
by sitting at a fixed distance from a computer screen and playing a type
of ‘computer game’, in which you try to catch a black spot on
the screen. This is done by pointing to each spot as it appears, using
a hand-held mouse. You will need to read the instructions beforehand and
you are also invited to complete a brief questionaire, so that we can
find out whether you have had any difficulties.
8. What is the procedure
that is being tested?
The procedure being tested is a visual field test,
in which you point to every new black spot that appears on a computer
screen.
9. What are the alternatives
for diagnosis or treatment?
There are many types of visual field test, but
few are simple enough for self-examination using a computer screen at
home. This is because conventional tests force the patient to keep the
eye still throughout the test, which is unnatural and difficult.
10. What are the side
effects of taking part?
There should not be any side effects.
11. What are the possible
disadvantages and risks of taking part?
There should not be any other disadvantages or
risks. At the moment, we do not know how reliable the test really is,
so that it is possible that you will get a normal result even if you have
a visual field defect. Conversely, you might get an abnormal result even
if your visual fields are entirely normal. Such a false alarm may cause
undue distress and unnecessary examinations by your doctor or optometrist.
We have taken every possible precaution to ensure that our program does
not harm your computer, but a with any software we cannot incur any liability
for any damage caused to your computer or any other software installed
in it.
12. What are the possible
benefits of taking part?
It is possible that you may detect a disease you
were not aware of. You will probably not benefit from taking part, but
we hope you will find the experience interesting and rewarding.
The information we
get from this study may help us to treat future patients better.
13. What if new information
becomes available?
As new information becomes available, we will update
our newsletter on our website, which you can visit at any time.
14. What happens when
the research study stops?
If the experimental work is successful, then we
would make this test more widely available over the internet.
15. What if something
goes wrong?
If you have any complaints to make about us you
can write to our hospital at the address given above. These will be handled
in the standard manner, following the normal hospital protocol.
If you are harmed
by taking part in this research project, there are no special compensation
arrangements. If you are harmed due to someone’s negligence, then
you may have grounds for a legal action but you may have to pay for it.
Regardless of this, if you wish to complain about any aspect of the way
you have been approached or treated during the course of this study, the
normal National Health Service complaints mechanisms may be available
to you.
16. Will my taking
part in this study be kept confidential?
All information which is collected about you during
the course of the research will be kept strictly confidential. Any information
about you which leaves our hospital will have your name and address removed
so that you cannot be recognised from it.
17. What will happen to the results of the research
study?
We hope that the results of this research will
eventually be published in an ophthalmic journal such as the British Journal
of Ophthalmology, probably in about a year’s time. You will not be
identified in any publication, whether this is in the form of a lecture
or a printed article.
18. Who is organising
and funding the research?
We are performing the visual field test using a
computer funded from the Eye Tumour Research Fund, consisting of donations
from our patients.
19. Who has reviewed
the study?
This study was reviewed by the Liverpool Research
Ethics Committee.
20. Contact for Further
Information
If you would like further information you can write
to us.
21. Memo to Practitioners
Multifixation Campimetry for Internet has been developed for situations
where conventional methods are not possible. It is not designed to compete
with established perimeters.
The sensitivity of
this test has been reduced to prevent false positive results. A more sensitive
version may be developed in future, testing more points with low contrast
stimuli.
The current version
of the test is designed only for use by persons who regularly use a computer.
An easier version of the test is in preparation, for children and elderly
patients.
This test is still
being evaluated and should not yet be used for clinical purposes. Information
regarding formal validation and certification will be shown on this page
in due course.
We would like this
test to be evaluated by independent workers and have developed an online
database for this purpose.If you would like to collaborate with us in
any research related to this test, please contact us by e-mail.
Mr Carl Groenewald
Consultant Ophthalmologist
Bertil Damato
Honorary Professor, Consultant Ophthalmologist
1.
I understand that my participation is voluntary
and that I am free to withdraw at any time without my medical
care or legal rights being affected.
2. I understand that
if I am a patient of the Royal Liverpool University
Hospital sections of any of my medical notes may be looked at
by responsible individuals from or by regulatory authorities
where it is relevant to my taking part in research.
I give permission for these individuals to have access to my
records. |