Strabismus Measurements Using Automated 3D Video Oculography

Strabismus Clinical Trial

Official title:

Strabismus Measurements Using Automated 3D Video Oculography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228070
• Other study ID #: KEK-ZH-Nr. 2014-0481
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: October 24, 2017
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Measuring ocular motility and alignment is important for diagnosing different causes of strabismus, following patients recovering from cranial nerve palsies, preparing patients for strabismus surgery and follow-up post surgery. The current clinical gold standards for measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are accurate, but require patient cooperation, and are not objective because the patient has to indicate the position of the light he sees on the screen. Our objective is to develop an accurate and easy to use goggles system to measure ocular alignment and motility using 3D video oculography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

Inclusion Criteria:

• Patients 11 years or older

• congenital strabismus

• acquired strabismus

• paretic strabismus (oculomotor, abducens and trochlear nerves)

• before and after strabismus surgery

• normal controls

Exclusion Criteria:

• Patients unable to sign informed consent

• Patients with significantly impaired vision

• Patients unable to cooperate with standard strabismus workup (including Hess and Harms tests)

• For sub-study: intolerance to scleral search coils

Related Conditions & MeSH terms

• Strabismus

Intervention

Device:
• strabismus video goggles

Locations

Country	Name	City	State
Switzerland	Ophthalmology Department, University Hospital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Albert Bruppacher-Stiftung, Stiftung OPOS zugunsten von Wahrnehmungsbehinderten

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Follow-up squint angle measures post-OP and after recovery from cranial nerve palsy with 3D video goggles and Hess/Harms screen	Change in squint angle with 3D video goggles and Hess/Harms screen.	initial visit, 3 months after surgery, recovery from cranial nerve palsy after 3 months
Primary	Validation of video goggles against Hess/Harms screen	Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.	initial visit
Secondary	Accuracy of video goggles in comparison to scleral search coils	Measurement of squint angle with 3D video goggles vs. scleral search coils.	initial visit