Steps of a clinical trial

Informed consent

 

In order to enroll you in a clinical trial, detailed information about the purpose, advantages, risks, examinations, number of visits, data protection and your rights as a study participant will be provided by one of our doctors. This information is again summarised in a written informed consent form and your signature on that form is mandatory in order to conduct the study-specific screening examinations.

 

Screening

 

The screening visit consists of different study-specific examinations according to the study´s protocol to evaluate whether all inclusion criteria are fulfilled.

 

Treatments

The type of treatment depends on the particular study. You will find a summary of all important study-specific aspects in your written informed consent.

 

 

Study examinations

Different visits are part of a clinical trial. You will find a summary of the examinations performed, their duration and further specifications in your written informed consent. The visits should be performed in a certain time period to assure statistical comparability of the results. Depending on the study, the visits can last from 15 minutes to 3 hours. Furthermore, some examinations require dilating the pupil for a better inspection of the implanted intraocular lens and/or the retina. In this case, you are not allowed to drive a vehicle by yourself or to work with machines as long as the effect lasts.

 

Medications

Depending on the study, the administration of certain medication can be necessary and will be recorded. It is therefore helpful if you could show us your actual medication schedule at the screening visit and please inform us about any changes in the course of the trial.

 

Adverse events

Adverse events may occur during the study. These events are often not related to the study but they have to be documented and if necessary be reported to regulatory authorities. Whenever you notice changes of your eyes or your health in general, we kindly ask you to contact us immediately. Depending on the event we will arrange an additional examination visit.

 

Your rights as a study patient

The right of withdrawal: As a study patient you may declare your withdrawal at any time during the study without stating a reason. We respect this wish at any time. A subsequent treatment at our clinic according to the current standards and guidelines is guaranteed - as for every other patient who is treated in our clinic.