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Register:	ISRCTN
Last refreshed on:	21 January 2020
Main ID:	ISRCTN54821973
Date of registration:	10/05/2017
Prospective Registration:	Yes
Primary sponsor:	Augenklinik Luzerner Kantonsspital [Cantonal Hospital Lucerne Eye Clinic]
Public title:	Effects of video presented information about Excimer laser therapy on comprehension and satisfaction with informed consent
Scientific title:	Effects of video presented information about excimer laser therapy on ametropic patients’ comprehension and satisfaction with the informed consent process: A randomized controlled trial
Date of first enrolment:	01/06/2017
Target sample size:	86
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN54821973
Study type:	Interventional
Study design:	Single-centre open randomized parallel controlled trial (Other)
Phase:	Not Applicable

Countries of recruitment
Switzerland

Contacts

Name:	Philipp Baenninger
Address:	Cantonal Hospital Lucerne Eye Clinic Augenklinik Luzerner Kantonsspital Spitalstrasse 6000 Lucerne Switzerland
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
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Affiliation:

Key inclusion & exclusion criteria

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

Exclusion criteria:
1. Inability to follow the procedures of the study due to i.e. language problems, psychological disorders, dementia etc
2. Aged < 18 years
3. Enrolment of the investigator, his/her family members, employees and other dependent persons

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Excimer laser treatment for ametropia
Eye Diseases
Excimer laser treatment for ametropia

Intervention(s)

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 la

Primary Outcome(s)

Patients knowledge is measured using five multiple choice questions with five statements after the consultation.

Secondary Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Cantonal Hospital Lucerne, Eye Clinic

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration.

Results

Results available:	Yes
Date Posted:
Date Completed:	01/01/2019
URL:

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