Condition category
Surgery
Date applied
21/06/2017
Date assigned
26/06/2017
Last edited
23/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Mr Thomas Vo

ORCID ID

Contact details

850 Health Sciences Road
Irvine
92697
United States of America

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

Sponsor information

Organisation

Gavin Herbert Eye Institute, University of California, Irvine

Sponsor details

850 Health Sciences Road
Irvine
92697
United States of America

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes