Video-assisted Informed Consent for Cataract Surgery

Sponsor
Guangzhou First People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02185807
Collaborator
(none)
80
2
2
8
40
5

Study Details

Study Description

Brief Summary

The investigators will investigate whether video-assisted informed consent is superior to routine discussion for cataract patients about risks, benefits and alternatives to receiving phacoemulsification cataract extract and intraocular lens implantation, and will determine whether video-assisted informed consent can reduce the work load of physicians.

Condition or Disease Intervention/Treatment Phase
  • Procedure: video-assisted group
  • Procedure: control group
N/A

Detailed Description

Patients with age-related cataract who scheduled for elective phacoemulsification cataract extract and intraocular lens implantation surgery and their physicians who on charge of these patients will be enrolled in the study. Patients will be randomized to the video assistance group watched a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians. The control group will receive traditional verbal information and discussion from their physicians. A questionnaire for patients will be administered to assess the comprehension and satisfaction with the informed consent process before surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does Video-assisted Informed Consent for Cataract Surgery Improve Patients' Satisfaction
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: video-assisted group

The video assistance patients watch a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians, and receive face- to face discussion with their physicians as well.

Procedure: video-assisted group
The video assistance patients watch a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians.

Placebo Comparator: control group

The control patients receive verbal information and discussion from their physicians.

Procedure: control group
The control patients receive verbal information and discussion from their physicians.

Outcome Measures

Primary Outcome Measures

  1. overall patients satisfaction with informed concent [The same day after the surgery]

Secondary Outcome Measures

  1. The proportion of patients refusing to sign consent [The same day of surgery]

    The proportion of patients who refuse to sign consent for the surgery

  2. A 10-question cataract surgery knowledge measure [The same day after the surgery]

    A written examination (0% to 100%) on patient understanding of the risks, benefits, and alternatives of cataract surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients with age-related cataract scheduled for elective phacoemulsification and intraocular lens implantation for the first time in Department of Ophthalmology, Affiliated Hospital of Guangdong Medical College will be recruited in this study. Recruited patients shall own normal intelligence and understanding capability and their best corrected visual acuity more than 0.1 in either eye.

Exclusion Criteria:

Patients who have undergone previously cataract surgery or whose best corrected visual acuity is lower than 0.1 in either eye or patients who complicated with complex other eye diseases such as uveitis and retinal detachment or patients whose language is not cantonese or mandarin will be excluded from this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanshui District People's Hospital of Foshan;Guangzhou First Peoples' Hospital, Affiliated Hospital of Guangzhou Medical University Foshan Guangdong China 528100
2 Guangzhou First Municipal People's Hospital Guangzhou Guangdong China 510180

Sponsors and Collaborators

  • Guangzhou First People's Hospital

Investigators

  • Principal Investigator: Yuehong Zhang, MD, PhD, Guangzhou First People's Hospital
  • Principal Investigator: Min Lu, MD, Sanshui District People's Hospital of Foshan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yuehong Zhang, Dr., Guangzhou First People's Hospital
ClinicalTrials.gov Identifier:
NCT02185807
Other Study ID Numbers:
  • GZFPH-IRB-2013-087
First Posted:
Jul 10, 2014
Last Update Posted:
Aug 16, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Yuehong Zhang, Dr., Guangzhou First People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2016