Video Diversion Improves Success Rate of Fundoscopic Examination in Children

Fundoscopy Clinical Trial

Official title:

Video Diversion Improves the Success Rate of Fundoscopic Examination in Children: a Prospective Multi-clinic, Multi-practitioner, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784132
• Other study ID #: H12-02053
• Status: Completed
• Phase: N/A
• First received: May 24, 2016
• Last updated: May 24, 2016
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy.

Description:

Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy. The authors plan to recruit from 4 different clinical care settings for a total of 101 subjects. Success rate is defined as visualizing the optic disc within 60 seconds from commencement of fundoscopy. The ease of examination is determined by using a 10 point likert scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 4 Years

Eligibility

Inclusion Criteria:

• patient aged 1 to 4 years of age (inclusive) with 2 examinable eyes

Exclusion Criteria:

• Patients who were blind, younger than 1 year of age, or older than 4 years of age

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fundoscopy

Intervention

Other:
• Video diversion
The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of visualizing the optic disc within 60 seconds		60 second	No
Secondary	Time required to visualize the optic disc		60 seconds	No
Secondary	Ease of performing fundoscopy		60 seconds	No