Video-assisted Informed Consent for Cataract Surgery

Guangzhou First People's Hospital80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cataract Surgery

Interventions

video-assisted groupPROCEDURE

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 groupPROCEDURE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

overall patients satisfaction with informed concent

Time frame: The same day after the surgery

Secondary Outcomes

The proportion of patients refusing to sign consent

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

Time frame: The same day of 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

Time frame: The same day after the surgery

Data from ClinicalTrials.gov

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