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Video-assisted Informed Consent for Cataract Surgery

Primary Purpose

Cataract, Surgery

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
video-assisted group
control group
Sponsored by
Guangzhou First People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract, surgery, consent process, video-assisted

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

video-assisted group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

overall patients satisfaction with informed concent

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2014
Last Updated
August 14, 2016
Sponsor
Guangzhou First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02185807
Brief Title
Video-assisted Informed Consent for Cataract Surgery
Official Title
Does Video-assisted Informed Consent for Cataract Surgery Improve Patients' Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou First People's Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Surgery
Keywords
cataract, surgery, consent process, video-assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
video-assisted group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control patients receive verbal information and discussion from their physicians.
Intervention Type
Procedure
Intervention Name(s)
video-assisted group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
control group
Intervention Description
The control patients receive verbal information and discussion from their physicians.
Primary Outcome Measure Information:
Title
overall patients satisfaction with informed concent
Time Frame
The same day after the surgery
Secondary Outcome Measure Information:
Title
The proportion of patients refusing to sign consent
Description
The proportion of patients who refuse to sign consent for the surgery
Time Frame
The same day of surgery
Title
A 10-question cataract surgery knowledge measure
Description
A written examination (0% to 100%) on patient understanding of the risks, benefits, and alternatives of cataract surgery
Time Frame
The same day after the surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuehong Zhang, MD, PhD
Organizational Affiliation
Guangzhou First People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min Lu, MD
Organizational Affiliation
Sanshui District People's Hospital of Foshan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanshui District People's Hospital of Foshan;Guangzhou First Peoples' Hospital, Affiliated Hospital of Guangzhou Medical University
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528100
Country
China
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Video-assisted Informed Consent for Cataract Surgery

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