Video-assisted Informed Consent for Cataract Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract, Surgery

Intervention / Treatment
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* Procedure: video-assisted group
* Procedure: control group


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: video-assisted group<br>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<br>* 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.<br>|
| Placebo Comparator: control group<br>The control patients receive verbal information and discussion from their physicians. | Procedure: control group<br>* The control patients receive verbal information and discussion from their physicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall patients satisfaction with informed concent |  | The same day after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, surgery, consent process, video-assisted