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Clinical Trials/NCT02185807
NCT02185807
Completed
Not Applicable

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

Guangzhou First People's Hospital2 sites in 1 country80 target enrollmentJuly 2014
ConditionsCataractSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Guangzhou First People's Hospital
Enrollment
80
Locations
2
Primary Endpoint
overall patients satisfaction with informed concent
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
March 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou First People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yuehong Zhang

Dr.

Guangzhou First People's Hospital

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.

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 same day of surgery)
  • A 10-question cataract surgery knowledge measure(The same day after the surgery)

Study Sites (2)

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