You can choose to end your participation in this study (called withdrawal) at any time without giving a reason. If you choose to withdraw, please contact the study doctor or a member of the study team.
Your study doctor may ask you to attend one final visit to check your eye health and safety before stopping your participation. You may also be asked a few short questions about your experience in the study.
Withdrawing will not affect the quality of your ongoing medical care at Moorfields Eye Hospital or your legal rights in any way.
The study doctor may stop your participation in the study early, and without your consent, for reasons such as:
You are unable to tolerate the study treatment.
You are unable to complete all required study procedures.
New information shows that the study treatment is no longer in your best interest.
The study doctor no longer feels this is the best option for you.
The Sponsor decides to stop the study.
The Regulatory Authority/ies or the research ethics board withdraws permission for this study to continue.
If you are withdrawn from this study, your doctor will discuss the reasons with you and plans will be made for your continued care outside of the study.
Moorfields Eye Hospital NHS Foundation Trust is the Sponsor of this research and is responsible for making sure that the study is properly designed, safely conducted, meets ethical standards, and that the results are collected and analysed according to national research criteria.
This study is being funded by Alcon Eye Care UK Limited through an unrestricted research grant. An unrestricted grant means that the company provides financial support for the study but has no influence or control over how the study is carried out, how the data are analysed, or what results are reported.
All aspects of the research—including study design, patient care, data collection, analysis, and publication of results—are independently managed by the investigators at Moorfields Eye Hospital.
All research in the United Kingdom is looked at by an independent body, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by South Central - Hampshire A Research Ethics Committee
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions. If you remain unhappy and wish to complain formally, you can do this by contacting the Site Patient Advice and Liaison Service (PALS) at Moorfields Eye Hospital, City Road from Monday to Friday 9am – 5pm by telephone 020 7566 2324 or 2325 or by email to moorfields.pals@nhs.net
If you are harmed as a result of taking part in this research and this is due to someone’s negligence, you may be able to claim compensation through the NHS complaints and legal processes. Moorfields Eye Hospital NHS Foundation Trust has NHS indemnity arrangements in place to cover negligent harm.
However, there is no special compensation scheme for harm that is not caused by anyone’s negligence. In such cases, you would not normally receive compensation.
The normal National Health Service complaints mechanisms will still be available to you.
Multifocal intraocular lens in bilateral cataract surgery is the G-PERFECT study. The study is sponsored by Moorfields Eye Hospital NHS Foundation Trust and funded by Alcon Eye Care UK Limited.