Video-assisted Informed Consent for Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract; Surgery
• Interventions: Procedure: video-assisted group; Procedure: control group

• Registration Number: NCT02185807
• Lead Sponsor: Guangzhou First People's Hospital

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.

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-14
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
video-assisted group	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.
control group	control group	The control patients receive verbal information and discussion from their physicians.

Primary Outcome Measures

Name	Time	Method
overall patients satisfaction with informed concent	The same day after the surgery

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Sanshui District People's Hospital of Foshan;Guangzhou First Peoples' Hospital, Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Foshan, Guangdong, China

Guangzhou First Municipal People's Hospital; 🇨🇳 Guangzhou, Guangdong, China