Video informed consent for cataract surgery
| 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
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
Public
850 Health Sciences Road
Irvine
92697
United States of America
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Multimedia-facilitated informed consent for cataract surgery: a randomized controlled trial |
| Study objectives | Use 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) studied | 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 |
| Primary outcome measure | 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 study start date | 09/06/2017 |
| Completion date | 01/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Any patient undergoing first time phaco cataract surgery for placement of a monofocal lens |
| Key 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 |
| Date of first enrolment | 09/06/2017 |
| Date of final enrolment | 01/09/2017 |
Locations
Countries of recruitment
- United States of America
Study participating centre
United States of America
Sponsor information
University/education
850 Health Sciences Road
Irvine
92697
United States of America
"ROR" |
https://ror.org/04gyf1771 |
|---|
Funders
Funder type
University/education
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 date | 01/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in an ophthalmology journal. |
| IPD sharing plan | 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. |
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.
