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Strabismus Measurements Using Automated 3D Video Oculography

NCT ID: NCT02228070

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Strabismus

Keywords

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strabismus oculomotor palsy abducens palsy trochlear palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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strabismus video goggles

Group Type EXPERIMENTAL

strabismus video goggles

Intervention Type DEVICE

Interventions

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strabismus video goggles

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albert Bruppacher-Stiftung

UNKNOWN

Sponsor Role collaborator

Stiftung OPOS zugunsten von Wahrnehmungsbehinderten

UNKNOWN

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ophthalmology Department, University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 28728924 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2014-0481

Identifier Type: -

Identifier Source: org_study_id