Strabismus Measurements Using Automated 3D Video Oculography

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT02228070
• Collaborator: Albert Bruppacher-Stiftung (Other), Stiftung OPOS zugunsten von Wahrnehmungsbehinderten (Other)
• Enrollment: 58
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Strabismus	Device: strabismus video goggles	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Strabismus Measurements Using Automated 3D Video Oculography
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: strabismus video goggles	Device: strabismus video goggles

Outcome Measures

Primary Outcome Measures

1. Validation of video goggles against Hess/Harms screen [initial visit]

   Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.

Secondary Outcome Measures

1. Accuracy of video goggles in comparison to scleral search coils [initial visit]

   Measurement of squint angle with 3D video goggles vs. scleral search coils.

Other Outcome Measures

1. Follow-up squint angle measures post-OP and after recovery from cranial nerve palsy with 3D video goggles and Hess/Harms screen [initial visit, 3 months after surgery, recovery from cranial nerve palsy after 3 months]

   Change in squint angle with 3D video goggles and Hess/Harms screen.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology Department, University Hospital Zurich	Zurich		Switzerland	CH-8091

Sponsors and Collaborators

• University of Zurich
• Albert Bruppacher-Stiftung
• Stiftung OPOS zugunsten von Wahrnehmungsbehinderten

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT02228070
• Other Study ID Numbers: KEK-ZH-Nr. 2014-0481
• First Posted: Aug 28, 2014
• Last Update Posted: Oct 26, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by University of Zurich: strabismus; oculomotor palsy; abducens palsy; trochlear palsy
• Additional relevant MeSH terms: Strabismus

Study Results

No Results Posted as of Oct 26, 2017