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Completed

NCT Number: NCT02228070

Strabismus Measurements Using Automated 3D Video Oculography

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.

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Key information

Conditions

Strabismus Abducens Nerve Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology Department, University Hospital Zurich

Zurich, CH-8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

strabismus video goggles

Device

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Albert Bruppacher-Stiftung
  • Stiftung OPOS zugunsten von Wahrnehmungsbehinderten

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2014
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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