Study title: Vision in pregnancy.
Women who are pregnant in their first trimester (within 90 days of their last period) are invited to participate in a clinical study investigating whether pregnancy affects vision.
The study is being organised by the researcher as part of a doctoral programme. The study receives no external funding from any organisation and is being carried out in conjunction with London South Bank University (LSBU) and The Institute of Optometry (IoO). The research has been approved by Research Ethics Committees of the NHS and of the academic institutions supervising the research (London South Bank University and Institute of Optometry).
Before you decide whether to participate, it is important that you understand why the research is being done and what it will involve. Please read carefully the following information. If you need further information regarding this study or have any questions, do not hesitate to contact the study researcher by email.
This information sheet describes your rights and obligations as a study participant.
Do you have to take part in the study?
You do not have to take part in the study and your participation is entirely voluntary. If you agree to participate you can decide at any time to stop participating. However, once you have completed questionnaires and vision tests, you can only be withdrawn up to the point of data analysis, which is likely to take place in April or May 2022. You are not required to justify your withdrawal and your present or future medical and optometric care will not be affected. If you do decide to stop, it would be appreciated if you could let the researcher know by email, although you do not have to do this.
Why is this study being performed?
The purpose of the study is to investigate whether pregnancy affects vision. This is to help eyecare practitioners provide information and guidance to pregnant women, for example on whether it is safe to prescribe the first pair of glasses or to change the prescription for glasses or contact lenses during pregnancy.
How and where will this clinical study be conducted?
This study will be conducted online. This can be done at your home using your desktop, laptop or tablet device
What would taking part involve?
Everyone taking part in the study is asked to complete an online questionnaire four times, once in each trimester and once after the birth. The questionnaire should take no longer than 10 minutes to complete. There is also an additional optional element, which can be completed after the questionnaire. This is an online vision test and full instructions are provided. The test should take around 10 minutes to complete.
We stress that we ask all participants to complete the questionnaire, but the vision test is optional. The results will be most useful if you can complete the vision test online when requested on all four occasions and please do so if you can.
On each occasion, we ask that you visit the website and complete the questionnaire (and, if you have time, the online vision test) within a week of receiving the invitation. We will remind you only twice each time you are due to visit the website and participate. If you miss one of these four occasions, we can still include you in the study. If you do not participate on two occasions when we send you an invitation, we will not be able to include your results and will not send you any further reminders.
Will the research discover new vision disorders?
The vision test used in the research assesses just one aspect of visual function and is not the same as a sight test or eye examination. The research is not designed to detect whether you have a new vision disorder. If you experience visual problems, you should consult your optometrist. If you do not have an optometrist, you should ask at any optical practice for an appointment with a community optometrist.
What are the possible benefits of taking part?
There are no benefits to you from taking part in the study but you will be helping to develop clinical guidance for community optometrists.
What are the possible disadvantages and risks of taking part?
Participating in this study is safe and will have no effect on you or your baby.
Are there any additional expenses or fees for potential participants?
There are no fees or expenses payable for participation in the study.
How will my information be kept confidential?
Your participation in the study will be recorded in a study clinical record. Your personal data collected for this trial will be anonymised using a unique participant identifier number (PIN). The collection and processing of your personal data will include contact details for you during the research, your date of birth and your baby’s anticipated birth date. This information will be stored on a password-protected database that is only accessed by the researcher. Study data will be used by the research team for analysing the results but this will not contain personal data (such as name, address, telephone numbers) and will only contain your PIN and data that are necessary to evaluate the results of this study. All data will be collected and processed with care to ensure confidentiality and compliance with applicable data privacy protection laws and regulations. Scientific publications will not mention the names of any participants and we will not take any images of participants. Consent forms will be kept for 5yrs with all patient identifiable data destroyed 6 months after the results are published and all other data 12 months after publication.
Who will have access to my data?
Only the research team will have access to your data. You have the right to request, through the study researcher, access to your personal data and the right to request rectification of any data that are not correct or complete.
Reasonable steps will be taken to respond to such a request, taking into consideration the nature of the request, the conditions of the study, and the applicable laws and regulations.
How can I read about the results of the research?
Our aim is to publish the outcomes of the research in the second half of 2022 and these will be available at search.datacite.org
What if I have concerns during my pregnancy?
If you have concerns about your pregnancy, you should contact your midwife or GP. If you have concerns about your general health, you should contact your GP. If you have concerns about your vision or eyes, you should contact your optometrist (if you do not have an optometrist, you can find a community optometrist at any local optical practice).
What if I have questions?
If you have any questions about the research or what is involved, please email the researcher.
What if something goes wrong?
If you have any concerns regarding the conduct of the study you can email the Chair of the ethics panel.
If you have any questions about the research, please contact the research team:
Thank you for taking the time to read this and for interest in the study.