Strabismus Measurements Using Automated 3D Video Oculography
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 26, 2017
October 1, 2017
1 year
August 25, 2014
October 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validation of video goggles against Hess/Harms screen
Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.
initial visit
Secondary Outcomes (1)
Accuracy of video goggles in comparison to scleral search coils
initial visit
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
initial visit, 3 months after surgery, recovery from cranial nerve palsy after 3 months
Study Arms (1)
strabismus video goggles
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients 11 years or older
- congenital strabismus
- acquired strabismus
- paretic strabismus (oculomotor, abducens and trochlear nerves)
- before and after strabismus surgery
- normal controls
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Albert Bruppacher-Stiftungcollaborator
- Stiftung OPOS zugunsten von Wahrnehmungsbehindertencollaborator
Study Sites (1)
Ophthalmology Department, University Hospital Zurich
Zurich, CH-8091, Switzerland
Related Publications (1)
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.
PMID: 28728924DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2014
First Posted
August 28, 2014
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
October 26, 2017
Record last verified: 2017-10