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Strabismus Measurements Using Automated 3D Video Oculography

Primary Purpose

Strabismus

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
strabismus video goggles
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Strabismus focused on measuring strabismus, oculomotor palsy, abducens palsy, trochlear palsy

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ophthalmology Department, University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

strabismus video goggles

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Accuracy of video goggles in comparison to scleral search coils
Measurement of squint angle with 3D video goggles vs. scleral search coils.

Full Information

First Posted
August 25, 2014
Last Updated
October 24, 2017
Sponsor
University of Zurich
Collaborators
Albert Bruppacher-Stiftung, Stiftung OPOS zugunsten von Wahrnehmungsbehinderten
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1. Study Identification

Unique Protocol Identification Number
NCT02228070
Brief Title
Strabismus Measurements Using Automated 3D Video Oculography
Official Title
Strabismus Measurements Using Automated 3D Video Oculography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Albert Bruppacher-Stiftung, Stiftung OPOS zugunsten von Wahrnehmungsbehinderten

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus
Keywords
strabismus, oculomotor palsy, abducens palsy, trochlear palsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
strabismus video goggles
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
strabismus video goggles
Primary Outcome Measure Information:
Title
Validation of video goggles against Hess/Harms screen
Description
Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.
Time Frame
initial visit
Secondary Outcome Measure Information:
Title
Accuracy of video goggles in comparison to scleral search coils
Description
Measurement of squint angle with 3D video goggles vs. scleral search coils.
Time Frame
initial visit
Other Pre-specified Outcome Measures:
Title
Follow-up squint angle measures post-OP and after recovery from cranial nerve palsy with 3D video goggles and Hess/Harms screen
Description
Change in squint angle with 3D video goggles and Hess/Harms screen.
Time Frame
initial visit, 3 months after surgery, recovery from cranial nerve palsy after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Ophthalmology Department, University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28728924
Citation
Weber KP, Rappoport D, Dysli M, Schmuckle Meier T, Marks GB, Bockisch CJ, Landau K, MacDougall HG. Strabismus Measurements with Novel Video Goggles. Ophthalmology. 2017 Dec;124(12):1849-1856. doi: 10.1016/j.ophtha.2017.06.020. Epub 2017 Jul 17.
Results Reference
derived

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Strabismus Measurements Using Automated 3D Video Oculography

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