Cyclofusion CompetenceNCT03322111
Assessment of Cyclofusion Capabilities of Normal Subjects and Patients With 3D Dynamic Random-dot Stereograms
A study testing measurement of the cyclofusion in people with Cyclofusion Competence, run by Cantonal Hospital of St. Gallen.
Trial summary
With this study the investigator wants measure the individual cyclofusion competence from healthy subjects and patients suffering from Strabismus with a only binocularly visible threedimensional Landolt-C stimulus. For this the participant has to look at a 3-D monitor with shutter glasses. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cyclofusion Competence
- What is being tested?
- measurement of the cyclofusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to 20 Apr 2019
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Visual acuity >0,4; Stereopsis
Who cannot join
- Visual acuity <0,4; no Stereopsis
About this study
With this study the investigator wants measure the individual cyclofusion competence from healthy subjects and patients suffering from Strabismus with a only binocularly visible threedimensional Landolt-C stimulus. For this the participant has to look at a 3-D monitor with shutter glasses. The participant is sitting in 2 meter distance in front of the monitor. On the monitor appears the Landolt-C stimulus as a dynamic Random-Dot Stimulus. As long as the participant can fuse the stimulus he will be able to see the Landolt C-ring threedimensional. The participant is then ask to tell in which direction the notch of the Landolt-C ring points out. Once a critical degree of cyclotorsion is reached the participant will no longer be able to see the Landolt C ring and the individual cyclofusion competence is reached.
- Conditions
- Cyclofusion Competence
- Being tested
- measurement of the cyclofusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of the cyclofusionDiagnostic test
Measurement of the maximal cyclofusion competence with a dynamic 3-D Random-Dot Landolt-C stimulus
| Study group | Role | What they receive |
|---|---|---|
| Cyclofusion | Experimental | Not described Receives: Diagnostic Test: measurement of the cyclofusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
In- and excyclofusion competence in healthy individuals. Change in In- and excyclofusion competence in patients who need a strabismus surgery before and 6 month after surgery.
The maximum in- and maximum excyclofusion competence will be measured with the described test set-up. The results will be documented in degree.
Measured: Once in healthy individuals. Before and 6 month after a (independent from the study) performed strabismus surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study startJan 2018 (estimated)
- Primary completion20 Apr 2019 (estimated)
- Study completion20 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclofusion CompetenceStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Veit Sturm, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322111
- Sponsor's protocol ID
- 2016-02118
- Other IDs
- 2016
- Status last verified
- Oct 2017
- First submitted
- 6 Oct 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Assessment of Cyclofusion Capabilities of Normal Subjects and Patients With 3D Dynamic Random-dot Stereograms
- ClinicalTrials.gov ID
- NCT03322111
- Acronym / sponsor ID
- 2016-02118
- Conditions
- Cyclofusion Competence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- 20 Apr 2019 (estimated)
- Study completion
- 20 Apr 2019 (estimated)
- First posted
- 26 Oct 2017 (actual)
- 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.
With this study the investigator wants measure the individual cyclofusion competence from healthy subjects and patients suffering from Strabismus with a only binocularly visible threedimensional Landolt-C stimulus. For this the participant has to look at a 3-D monitor with shutter glasses. The participant is sitting in 2 meter distance in front of the monitor. On the monitor appears the Landolt-C stimulus as a dynamic Random-Dot Stimulus. As long as the participant can fuse the stimulus he will be able to see the Landolt C-ring threedimensional. The participant is then ask to tell in which direction the notch of the Landolt-C ring points out. Once a critical degree of cyclotorsion is reached the participant will no longer be able to see the Landolt C ring and the individual cyclofusion competence is reached.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclofusion | Experimental | Diagnostic Test: measurement of the cyclofusion |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Visual acuity >0,4; Stereopsis
Key exclusion criteria (1 listed)
- Visual acuity <0,4; no Stereopsis
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 |
|---|---|---|
| measurement of the cyclofusionMeasurement of the maximal cyclofusion competence with a dynamic 3-D Random-Dot Landolt-C stimulus | Diagnostic test | Cyclofusion |
Primary outcome
In- and excyclofusion competence in healthy individuals. Change in In- and excyclofusion competence in patients who need a strabismus surgery before and 6 month after surgery.
Time frame: Once in healthy individuals. Before and 6 month after a (independent from the study) performed strabismus surgery.
The maximum in- and maximum excyclofusion competence will be measured with the described test set-up. The results will be documented in degree.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of the cyclofusion in people with Cyclofusion Competence, run by Cantonal Hospital of St. Gallen.
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 1 inclusion and 1 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: status not confirmed, 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.
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?
Results are not available in the source record.
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?
In- and excyclofusion competence in healthy individuals. Change in In- and excyclofusion competence in patients who need a strabismus surgery before and 6 month after surgery. (time frame: Once in healthy individuals. Before and 6 month after a (independent from the study) performed strabismus surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.