Video-assisted Informed Consent for Cataract Surgery

NCT02185807 | Completed

• 1 other identifier: GZFPH-IRB-2013-087
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Cataract; Surgery

Keywords

cataract; surgery; consent process; video-assisted

Outcome Measures

Primary Outcomes (1)

• overall patients satisfaction with informed concent

  The same day after the surgery

Secondary Outcomes (2)

• The proportion of patients refusing to sign consent

  The same day of surgery

• A 10-question cataract surgery knowledge measure

  The same day after the surgery

Study Arms (2)

video-assisted group

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

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

Procedure: control group

Interventions

video-assisted group 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.

video-assisted group

control group PROCEDURE

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

control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (2)

Sanshui District People's Hospital of Foshan;Guangzhou First Peoples' Hospital, Affiliated Hospital of Guangzhou Medical University

Foshan, Guangdong, 528100, China

Location

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

Location

MeSH Terms

Conditions

Cataract

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yuehong Zhang, MD, PhD

  Guangzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

• Min Lu, MD

  Sanshui District People's Hospital of Foshan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

CN (2)