Video-assisted Informed Consent for Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

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.

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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.

Conditions

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Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

video-assisted group

Intervention Type PROCEDURE

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 group

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

Group Type PLACEBO_COMPARATOR

control group

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

control group

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

Intervention Type PROCEDURE

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No