Video-assisted Informed Consent for Cataract Surgery

Does Video-assisted Informed Consent for Cataract Surgery Improve Patients' Satisfaction

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Surgery
• Intervention / Treatment: Procedure: video-assisted group; Procedure: control group

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528100
      • Sanshui District People's Hospital of Foshan;Guangzhou First Peoples' Hospital, Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First Municipal People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall patients satisfaction with informed concent	The same day after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients refusing to sign consent	The proportion of patients who refuse to sign consent for the surgery	The same day of surgery
A 10-question cataract surgery knowledge measure	A written examination (0% to 100%) on patient understanding of the risks, benefits, and alternatives of cataract surgery	The same day after the surgery

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 7, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 14, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: surgery; cataract; video-assisted; consent process
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: GZFPH-IRB-2013-087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED