Ganglion CellsNCT02407886
Retinal Ganglion Cell Layer in Patients With Intracerebral Processes
An observational study of Ganglion Cells, run by University of Zurich at 1 site in Switzerland.
Trial summary
Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans, retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to occur following prenatal or perinatal lesions… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ganglion Cells
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to May 2016
- Phase
- Observational
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with intracerebral lesions
Who may be able to join
- adult patients with intracerebral lesions within the central visual tract
- associated visual field defects
- investigations (OCT, ERG) possible
Who cannot join
- lesions within the optic nerve without extension in the optic tract
- neurological disease
- optic disc anomalies: glaucoma, nystagmus, high myopia
Trial locations and contacts
1 site in 1 country.
About this study
Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans, retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in adults is considerable rare. It is, however, well established that retrograde transsynaptic degeneration affects other neural systems in humans even when the injury occurs during adulthood. Some histopathological evidence points to the possibility of transsynaptic degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults, but the clinical significance is unknown.'
Purpose:
Read more
To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to intracerebral processes. To correlate GCL with the localization and type of intracerebral lesion.
To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2 parameters is more sensitive to show retinal layer abnormalities.
To correlate GCL with visual field defects and electrophysiological parameters.
- Conditions
- Ganglion Cells
What is being measured
The primary outcome is the main question the study is designed to answer.
Ganglion cell thickness
Measured: measurements will be taken at a minimum of 4 weeks after the inital diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ganglion CellsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Gerth-Kahlert, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407886
- Sponsor's protocol ID
- 2014-0649
- Status last verified
- May 2017
- First submitted
- 5 Mar 2015
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Ganglion Cell Layer in Patients With Intracerebral Processes
- ClinicalTrials.gov ID
- NCT02407886
- Acronym / sponsor ID
- 2014-0649
- Conditions
- Ganglion Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Apr 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.
Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans, retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in adults is considerable rare. It is, however, well established that retrograde transsynaptic degeneration affects other neural systems in humans even when the injury occurs during adulthood. Some histopathological evidence points to the possibility of transsynaptic degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults, but the clinical significance is unknown.'
Purpose:
To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to intracerebral processes. To correlate GCL with the localization and type of intracerebral lesion.
To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2 parameters is more sensitive to show retinal layer abnormalities.
To correlate GCL with visual field defects and electrophysiological parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with intracerebral lesions
Key inclusion criteria (3 listed)
- adult patients with intracerebral lesions within the central visual tract
- associated visual field defects
- investigations (OCT, ERG) possible
Key exclusion criteria (3 listed)
- lesions within the optic nerve without extension in the optic tract
- neurological disease
- optic disc anomalies: glaucoma, nystagmus, high myopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ganglion cell thickness
Time frame: measurements will be taken at a minimum of 4 weeks after the inital diagnosis
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 25 May 2017.
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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.
Christina Gerth-Kahlert, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ganglion Cells, 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 3 inclusion and 3 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 25 May 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?
Ganglion cell thickness (time frame: measurements will be taken at a minimum of 4 weeks after the inital diagnosis). 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 25 May 2017.