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Strabismus Measurements Using Automated 3D Video Oculography

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ClinicalTrials.gov Identifier: NCT02228070
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Albert Bruppacher-Stiftung
Stiftung OPOS zugunsten von Wahrnehmungsbehinderten
Information provided by (Responsible Party):
University of Zurich

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Strabismus Measurements Using Automated 3D Video Oculography
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Validation of video goggles against Hess/Harms screen [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228070


Locations
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Switzerland
Ophthalmology Department, University Hospital Zurich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Albert Bruppacher-Stiftung
Stiftung OPOS zugunsten von Wahrnehmungsbehinderten

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02228070     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2014-0481
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by University of Zurich:
strabismus
oculomotor palsy
abducens palsy
trochlear palsy
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases