Video-assisted Informed Consent for Cataract Surgery
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 |
---|---|---|
|
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
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
- overall patients satisfaction with informed concent [The same day after the surgery]
Secondary Outcome Measures
- 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
Eligibility Criteria
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.
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.- GZFPH-IRB-2013-087