Trochlear Nerve DiseasesCySLONCT02631369
Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs
A study testing Heidelberg Spectralis OCT device in people with Trochlear Nerve Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm by Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment of the influence of measuring with or without eye tracker. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trochlear Nerve Diseases
- What is being tested?
- Heidelberg Spectralis OCT device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2015to Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- best corrected visual acuity ≥ 0.8
Who cannot join
- strabismus except for forth nerve palsy
- previous strabismus surgery
- monocle
- best corrected visual acuity ≤ 0.6
- hyperopia or myopia > 6dpt
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Dept of Ophthalmology
Zurich, Canton of Zurich, 8091
About this study
Official title: Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs Using the Integrated Algorithm by Heidelberg Spectralis
Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm by Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment of the influence of measuring with or without eye tracker.
Study: Comparison of cyclotorsion measurements in patients with forth nerve palsy and in healthy controls on SLO-fundus fotographs using the integrated algorithm by Heidelberg Spectralis
- Conditions
- Trochlear Nerve Diseases
- Being tested
- Heidelberg Spectralis OCT device
- Medical subject headings
- Trochlear Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heidelberg Spectralis OCT deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| inter- & intrarater reliability study | Experimental | pre-study: inter- and intrarater reliability study in 30 healthy subjects, interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device Receives: Device: Heidelberg Spectralis OCT device |
| cyclotorsion in forth nerve palsy | Experimental | measurement of cyclotorsion on SLO-fundusphoto in 20 patients forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device Receives: Device: Heidelberg Spectralis OCT device |
| cyclotorsion in healthy subjects | Experimental | measurement of cyclotorsion on SLO-fundusphoto in 30 healthy subjects to be compared to patients with forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device Receives: Device: Heidelberg Spectralis OCT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-study: reliability of repeated measurements of excyclotorsion in degrees on SLO-fundus fotographs
pre-study: inter- and intrarater reliability of the device with or without eye tracker; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis
Measured: 3 months
study: excyclotorsion in degrees on SLO-fundus fotographs
study: comparison of cyclotorsion measurements in healthy controls compared to patients with forth nerve palsy; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis
Measured: 12 months
Secondary outcomes (1)
study: excyclotorsion in degrees on tangent screen, double maddox and fundus photographs
validation of the cyclotorsion measurement with the Heidelberg Spectralis device against tangent screen [degrees], double maddox [degrees] and fundus photographs [degrees]
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017
- Study completionDec 2017
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 Trochlear Nerve DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghislaine L Traber, MD, Principal investigator, University Hospital Zurich, Dept of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631369
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0404
- Acronym
- CySLO
- Status last verified
- Jun 2018
- First submitted
- 9 Dec 2015
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lengwiler F, Rappoport D, Jaggi GP, Landau K, Traber GL. Reliability of Cyclotorsion measurements using Scanning Laser Ophthalmoscopy imaging in healthy subjects: the CySLO study. Br J Ophthalmol. 2018 Apr;102(4):535-538. doi: 10.1136/bjophthalmol-2017-310396. Epub 2017 Aug 1.
PubMed 28765146
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs Using the Integrated Algorithm by Heidelberg Spectralis
- ClinicalTrials.gov ID
- NCT02631369
- Acronym / sponsor ID
- CySLO / KEK-ZH-Nr. 2014-0404
- Conditions
- Trochlear Nerve Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Dec 2015 (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.
Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm by Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment of the influence of measuring with or without eye tracker.
Study: Comparison of cyclotorsion measurements in patients with forth nerve palsy and in healthy controls on SLO-fundus fotographs using the integrated algorithm by Heidelberg Spectralis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inter- & intrarater reliability study | Experimental | Device: Heidelberg Spectralis OCT devicepre-study: inter- and intrarater reliability study in 30 healthy subjects, interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device |
| cyclotorsion in forth nerve palsy | Experimental | Device: Heidelberg Spectralis OCT devicemeasurement of cyclotorsion on SLO-fundusphoto in 20 patients forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device |
| cyclotorsion in healthy subjects | Experimental | Device: Heidelberg Spectralis OCT devicemeasurement of cyclotorsion on SLO-fundusphoto in 30 healthy subjects to be compared to patients with forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years old
- best corrected visual acuity ≥ 0.8
Key exclusion criteria (5 listed)
- strabismus except for forth nerve palsy
- previous strabismus surgery
- monocle
- best corrected visual acuity ≤ 0.6
- hyperopia or myopia > 6dpt
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 |
|---|---|---|
| Heidelberg Spectralis OCT device | Device | cyclotorsion in forth nerve palsy, cyclotorsion in healthy subjects, inter- & intrarater reliability study |
Primary outcome
pre-study: reliability of repeated measurements of excyclotorsion in degrees on SLO-fundus fotographs
Time frame: 3 months
pre-study: inter- and intrarater reliability of the device with or without eye tracker; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis
study: excyclotorsion in degrees on SLO-fundus fotographs
Time frame: 12 months
study: comparison of cyclotorsion measurements in healthy controls compared to patients with forth nerve palsy; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis
1 secondary outcome
study: excyclotorsion in degrees on tangent screen, double maddox and fundus photographs
Time frame: 12 months
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 13 Jun 2018.
- Derived from this study: PubMed 28765146Lengwiler F, Rappoport D, Jaggi GP, Landau K, Traber GL. Reliability of Cyclotorsion measurements using Scanning Laser Ophthalmoscopy imaging in healthy subjects: the CySLO study. Br J Ophthalmol. 2018 Apr;102(4):535-538. doi: 10.1136/bjophthalmol-2017-310396. Epub 2017 Aug 1.
Related trials for Trochlear Nerve Diseases
RecruitingObservational study
Genetic Studies of Strabismus, Congenital Cranial Dysinnervation Disorders (CCDDs), and Their Associated Anomalies
Congenital Fibrosis of Extraocular Muscles, Duane Retraction Syndrome
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.
Ghislaine L Traber, MD principal investigator
University Hospital Zurich, Dept of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heidelberg Spectralis OCT device in people with Trochlear Nerve Diseases, 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 2 inclusion and 5 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 13 Jun 2018. 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?
pre-study: reliability of repeated measurements of excyclotorsion in degrees on SLO-fundus fotographs (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02631369, 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 13 Jun 2018.