Effects of video presented information about Excimer laser therapy on comprehension and satisfaction with informed consent

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Potentially eligible participants treated at the refractive centre of the cantonal hospital Lucerne (LUKS) are informed about the existence of the study by their treating ophthalmologist. During an initial consultation, the ophthalmologist ask if a the participant is interested in participating in the study. Participants are asked to give written informed consent for study inclusion and usage of clinical data. Participants are randomised either to the non‐interventional group (verbal conventional informed consent) or to the interventional group (verbal and video‐assisted interventional informed consent) prior to their refractive excimer laser therapy. The randomisation is pre‐stratified for age (under 38 years versus older than 38 years), due to the management and expectations of participants approaching the phase of presbyopia might slightly differ. Randomisation is done using “REDCap” in a 1:1 allocation into the non‐/intervention group respectively. The randomisation is not blinded. Non‐interventional group: Participants receive a standard consultation for informed consent done to the standard level of care. This involves information about the treatment in oral and written form. The informed consent process includes information about benefits, risks, adverse events of and reasonable alternatives to refractive excimer laster therapy. In addition, ophthalmologists address individual factors of a specific patient that might affect therapy outcome. Finally, ophthalmologists answers patients’ remaining uncertainties and clarify ambiguities. Interventional group: Participants receive a verbal and video‐assited informed consent process. This includes standardised oral information about refractive excimer laser therapy exchanged by a video. Similar to the non‐interventional group, standardised information about the intervention in written form is also provided. Ophthalmologists also address individual factors of a specific patient that might affect therapy outcome a CONDITION: Excimer laser treatment for ametropia ; Eye Diseases ; Excimer laser treatment for ametropia PRIMARY OUTCOME: Patients knowledge is measured using five multiple choice questions with five statements after the consultation. SECONDARY OUTCOME: 1. Patients’ satisfaction is measured using a questionnaire after the consultation. ; 2. Anxiety levels is measured using a subpart of the State‐Trait Anxiety Inventory 42 after the consultation.; 3. Perceived contact time measured using a questionnaire after the consultation. INCLUSION CRITERIA: 1. Patients assessing refractive excimer laser therapy for ametropia at the refractive centre of the LUKS will be evaluated at their initial visit for study inclusion 2. Signed written informed consent form
Epistemonikos ID: 209c173940201d971a09838e9a63721a94ef78f0
First added on: Aug 24, 2024