ISRCTN ISRCTN16303856
DOI https://doi.org/10.1186/ISRCTN16303856
Secondary identifying numbers 2017-3626
Submission date
21/06/2017
Registration date
26/06/2017
Last edited
26/11/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Thomas Vo
Public

850 Health Sciences Road
Irvine
92697
United States of America

Study information

Study designSingle-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleMultimedia-facilitated informed consent for cataract surgery: a randomized controlled trial
Study objectivesUse of patient education videos will reduce the time needed to complete the informed consent process.
Ethics approval(s)Institutional Review Board at the University of California, Irvine, 06/08/2017, ref: HS#2017-3626
Health condition(s) or problem(s) studiedCataract surgery
InterventionPatients 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date09/06/2017
Completion date01/09/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteriaAny patient undergoing first time phaco cataract surgery for placement of a monofocal lens
Key exclusion criteria1. Patients unable to view/hear a video on a tablet device
2. Patient unable to give informed consent
3, Patient unable to speak English
Date of first enrolment09/06/2017
Date of final enrolment01/09/2017

Locations

Countries of recruitment

  • United States of America

Study participating centre

Gavin Herbert Eye Institute at the University of California, Irvine
92697
United States of America

Sponsor information

Gavin Herbert Eye Institute, University of California, Irvine
University/education

850 Health Sciences Road
Irvine
92697
United States of America

ROR logo "ROR" https://ror.org/04gyf1771

Funders

Funder type

University/education

University of California, Irvine
Government organisation / Universities (academic only)
Alternative name(s)
UC Irvine, Irvine, University of California Irvine, Pacific School of Osteopathy, Pacific College of Osteopathy, Los Angeles College of Osteopathy, California College of Osteopathic Physicians and Surgeons, California College of Medicine, UCI
Location
United States of America

Results and Publications

Intention to publish date01/09/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in an ophthalmology journal.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 10/08/2018 26/11/2021 Yes No

Editorial Notes

26/11/2021: Publication reference added.