Video-assisted Informed Consent for Cataract Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185807
• Other study ID #: GZFPH-IRB-2013-087
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: August 14, 2016
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2016
• Source: Guangzhou First Municipal People’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Surgery

Intervention

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

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First Municipal People’s Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall patients satisfaction with informed concent		The same day after the surgery	No
Secondary	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	No
Secondary	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	No