Can we improve knowledge of patients with keratoconus with educational material?

ISRCTN ISRCTN75317089
DOI https://doi.org/10.1186/ISRCTN75317089
Secondary identifying numbers 2020-001
Submission date
06/01/2020
Registration date
10/01/2020
Last edited
11/06/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aim:
Keratoconus is an eye disease in which the normally round cornea thins and begins to bulge into a conical shape. This cone shape deflects light as it enters the eye and therefore causes distortion of vision. This study intends to investigate the benefit of educational material to improve the patient’s knowledge of the disease.

Who can participate?
Everyone who was previously diagnosed with keratoconus, who is older than 18 years can participate in the study at the Eye clinic of Cantonal Hospital of Lucerne.

What does the study involve?
The interventional group of patients will watch an educational material and answer control questions about this material before the consultation with the eye doctor. The patients in the interventional as well as the control group will fill out a questionnaire assessing their keratoconus knowledge after the consultation.

Benefits and risks of participating?
There are no risks of participating but the benefit for the participants is a better understanding of the disease, which will help the participant to make decisions on treatment options together with the doctor.

Where is the study run from?
The special corneal clinic at the Eye Clinic of Cantonal Hospital of Lucerne (Switzerland)

When is the study starting and how long is it expected to run for?
October 2019 to July 2020

Who is funding the study?
The Eye Clinic of the Cantonal Hospital of Lucerne (Switzerland)

Who is the main contact?
Philipp Baenninger, philipp.baenninger@luks.ch

Contact information

Dr Philipp Baenninger
Public

Augenklinik Luzerner Kantonsspital
Spitalstrasse
Lucerne
6000
Switzerland

ORCiD logoORCID ID 0000-0001-8118-2464
Phone +41 412053312
Email philipp.baenninger@luks.ch

Study information

Study designSingle-centre single-blinded randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleThe effect of an educational intervention to improve knowledge of patients with keratoconus attending a pre-intervention consultation – a randomized controlled trial
Study objectivesKeratoconus is a progressive, ectatic corneal disease in which the normally round cornea thins and begins to bulge into a conical shape. This cone shape deflects light as it enters the eye on its way to the light-sensitive retina and causes distortion of vision.
This study intends to investigate the benefit of an educational measure prior to a consultation with a physician regarding the knowledge of keratoconus. This will help us to further develop and design the information material for keratoconus patients. By improving the knowledge about keratoconus we hope to indirectly improve the decision making of keratoconus patients.
Ethics approval(s)The local ethical committee reviewed the protocol of this study and found that it would not fall under the Human Research Act
Health condition(s) or problem(s) studiedKeratoconus
InterventionMeasurements and Randomization:
Potentially eligible patients treated at the corneal clinic of the LUKS will be informed about the existence of the study by the administrative staff of the clinic. If a patient is interested to take part, written informed consent will be sought for study inclusion and usage of clinical data. All participants will be informed that they have the right to withdraw from the study at any time without any disadvantage and without having to provide their reason for this decision. Subjects will not undergo any study specific procedures until they have provided written consent by signing the informed consent form, which will also be signed by the person obtaining the consent.

Participating patients will be randomized at the clinical trial centre (outside the hospital) using the Stata 16.0 randomization routines. Randomization will be made with a 1:1 allocation ratio and using blocks of 2 and 4. The randomization list will be kept at the trial centre (concealed) and caregivers at the consultation will be blinded to the allocation.

Prior to the consultation of the interventional group, standardized oral information about keratoconus will be provided via the multifaceted educational material. The time taken to digest the material and answer the control questions will not exceed 10 min.

Both groups will spend another 5 min to fill out the questionnaire assessing their keratoconus knowledge after the consultation.

Intervention:
The educational material shows different animated scenes giving the same standardized information on keratoconus as the treating ophthalmologist gives in regular face-to-face consultation. The material was developed in collaboration with members of the medical faculty of the University of Zurich and a group of clinical experts at the eye clinic of the LUKS in January 2020. The duration of the multifaceted educational intervention takes about 5 min.

Control intervention:
Patients randomized to the non-interventional group will receive a standard consultation representing best practice.
Intervention typeBehavioural
Primary outcome measureKnowledge on keratoconus as assessed by an assessment form containing six multiple-choice questions designed according to information gathered in the previous minimum keratoconus study. Distribution of baseline parameters will be assessed and parameters deviating 10% or more between groups will be entered as covariates for the efficacy analyses to reduce the risk for confounding. The effects of the intervention on the primary outcome will be estimated using regression modeling. The assessment form will be provided directly after the intervention or control material.
Secondary outcome measures1. Stage of keratoconus
2. Previous treatments for keratoconus
3. Sex, age and highest level of education

These data will also be collected in the assessment form directly after the intervention or control material.
Overall study start date01/10/2019
Completion date02/07/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Total final enrolment43
Key inclusion criteria1. Previously diagnosed keratoconus on at least one eye
2. Signed written informed consent
Key exclusion criteria1. 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
Date of first enrolment01/03/2020
Date of final enrolment26/06/2020

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Augenklinik Luzerner Kantonsspital [Cantonal Hospital of Lucerne Eye Clinic]
Spitalstrasse
Lucerne
6000
Switzerland

Sponsor information

Augenklinik Luzerner Kantonsspital [Cantonal Hospital of Lucerne Eye Clinic]
Hospital/treatment centre

Spitalstrasse
Lucerne
6000
Switzerland

Phone +41 412052835
Email michael.thiel@luks.ch
Website https://www.luks.ch/
ROR logo "ROR" https://ror.org/02zk3am42

Funders

Funder type

Hospital/treatment centre

Augenklinik Luzerner Kantonsspital [Cantonal Hospital of Lucerne Eye Clinic]

No information available

Results and Publications

Intention to publish date30/06/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe data that support the findings of this study are available from the corresponding author, Philipp Baenninger, upon reasonable request.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 24/10/2022 11/06/2025 Yes No

Editorial Notes

11/06/2025: Publication reference added.
17/12/2021: The intention to publish date was changed from 31/12/2021 to 30/06/2022.
27/07/2020: The following changes were made to the trial record:
1. Ethics approval details added.
2. The recruitment end date was changed from 01/10/2020 to 26/06/2020.
3. The overall trial end date was changed from 31/12/2020 to 02/07/2020.
4. Total final enrolment number added.
13/01/2020: Internal review.
10/01/2020: Trial’s existence confirmed by Cantonal Hospital Lucerne.