StrabismusNCT02228070
Strabismus Measurements Using Automated 3D Video Oculography
A study testing strabismus video goggles in people with Strabismus, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Strabismus
- What is being tested?
- strabismus video goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients 11 years or older
- congenital strabismus
- acquired strabismus
- paretic strabismus (oculomotor, abducens and trochlear nerves)
- before and after strabismus surgery
- normal controls
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ophthalmology Department, University Hospital Zurich
Zurich, CH-8091
About this study
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.
- Conditions
- Strabismus
- Being tested
- strabismus video goggles
- Keywords
- strabismus, oculomotor palsy, abducens palsy, trochlear palsy
- Medical subject headings
- Strabismus, Abducens Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strabismus video gogglesDevice
| Study group | Role | What they receive |
|---|---|---|
| strabismus video goggles | Experimental | Not described Receives: Device: strabismus video goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of video goggles against Hess/Harms screen
Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.
Measured: initial visit
Secondary outcomes (1)
Accuracy of video goggles in comparison to scleral search coils
Measurement of squint angle with 3D video goggles vs. scleral search coils.
Measured: initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Bruppacher-Stiftung, Stiftung OPOS zugunsten von Wahrnehmungsbehinderten
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228070
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0481
- Status last verified
- Oct 2017
- First submitted
- 25 Aug 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
Publications
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.
PubMed 28728924
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strabismus Measurements Using Automated 3D Video Oculography
- ClinicalTrials.gov ID
- NCT02228070
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0481
- Conditions
- Strabismus
- Keywords
- strabismus, oculomotor palsy, abducens palsy, trochlear palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Albert Bruppacher-Stiftung, Stiftung OPOS zugunsten von Wahrnehmungsbehinderten
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| strabismus video goggles | Experimental | Device: strabismus video goggles |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 11 years or older
- congenital strabismus
- acquired strabismus
- paretic strabismus (oculomotor, abducens and trochlear nerves)
- before and after strabismus surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strabismus video goggles | Device | strabismus video goggles |
Primary outcome
Validation of video goggles against Hess/Harms screen
Time frame: initial visit
Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.
1 secondary outcome
Accuracy of video goggles in comparison to scleral search coils
Time frame: initial visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Derived from this study: PubMed 28728924Weber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strabismus video goggles in people with Strabismus, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of video goggles against Hess/Harms screen (time frame: initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.