Strabismus Measurements Using Automated 3D Video Oculography

October 24, 2017 updated by: University of Zurich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Ophthalmology Department, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of video goggles against Hess/Harms screen
Time Frame: initial visit
Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.
initial visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
initial visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
initial visit, 3 months after surgery, recovery from cranial nerve palsy after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Albert Bruppacher-Stiftung
Stiftung OPOS zugunsten von Wahrnehmungsbehinderten

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2014-0481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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