Clinical trial NCT02185807: Video-assisted Informed Consent for Cataract Surgery
Official title: Does Video-assisted Informed Consent for Cataract Surgery Improve Patients' Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Surgery
Keywords: cataract
surgery
consent process
video-assisted
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: overall patients satisfaction with informed concent
timeFrame: The same day after the surgery
Secondary outcomes:
measure: The proportion of patients refusing to sign consent
timeFrame: The same day of surgery
measure: A 10-question cataract surgery knowledge measure
timeFrame: The same day after the surgery
Other outcomes:
Locations:
city: Foshan
country: China
facility: Sanshui District People's Hospital of Foshan;Guangzhou First Peoples' Hospital, Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First People's Hospital
name: Yuehong Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanshui District People's Hospital of Foshan
name: Min Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: