Plain English Summary
Background and study aims
Cataracts occur when changes in the lens of the eye cause it to become less transparent, causing cloudy, blurry, or misty vision. Cataract surgery involves removing the cloudy lens through a small cut in the eye and replacing it with a clear, plastic lens. The aim of this study is to assess the benefits of showing patient education videos to patients considering cataract surgery.
Who can participate?
Patients undergoing cataract surgery for the first time
What does the study involve?
Participants are randomly allocated to either watch the educational video before meeting with their surgeon for counselling, or to just receive face-to-face counseling with their surgeon. Participants are then asked to complete a short questionnaire at the end of their visit to assess their comprehension and satisfaction.
What are the possible benefits and risks of participating?
Participants may learn more about their surgery by viewing a patient education video. No risks are anticipated as the video shown was carefully produced by the American Academy of Ophthalmology.
Where is the study run from?
Gavin Herbert Eye Institute at the University of California, Irvine (USA)
When is the study starting and how long is it expected to run for?
June 2017 to September 2017
Who is funding the study?
University of California, Irvine (USA)
Who is the main contact?
Mr Thomas Vo
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2017-3626
Study information
Scientific title
Multimedia-facilitated informed consent for cataract surgery: a randomized controlled trial
Acronym
Study hypothesis
Use of patient education videos will reduce the time needed to complete the informed consent process.
Ethics approval
Institutional Review Board at the University of California, Irvine, 06/08/2017, ref: HS#2017-3626
Study design
Single-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Cataract surgery
Intervention
Patients will be randomized through a coin flip to either view the education video prior to counseling from a surgeon or routine face-to-face counseling with a surgeon alone. Patients will be asked to complete a short questionnaire at the conclusion of their visit that will assess comprehension and satisfaction.
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. Time to complete the informed consent process, measured at the end of the informed consent process
2. Comprehension and satisfaction, assessed through a self-administered questionnaire at the end of their preoperative appointment (same day)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
09/06/2017
Overall trial end date
01/09/2017
Reason abandoned
Eligibility
Participant inclusion criteria
Any patient undergoing first time phaco cataract surgery for placement of a monofocal lens
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patients unable to view/hear a video on a tablet device
2. Patient unable to give informed consent
3, Patient unable to speak English
Recruitment start date
09/06/2017
Recruitment end date
01/09/2017
Locations
Countries of recruitment
United States of America
Trial participating centre
Gavin Herbert Eye Institute at the University of California, Irvine
92697
United States of America
Funders
Funder type
University/education
Funder name
University of California, Irvine
Alternative name(s)
UC Irvine, Irvine, UCI
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in an ophthalmology journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as the datasets will not have any value beyond the scope of the study.
Intention to publish date
01/09/2018
Participant level data
Not expected to be available
Results - basic reporting
Publication summary