Optic NeuritisPCTNCT02894281
Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease
An observational study of Optic Neuritis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis confirmation is important to start proper treatment, because a NORB is often the first symptom of multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- pupillary light reflex
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to 30 Jun 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with no optic neuritis are recruited, to be compared with a database of 22 patients already recruited in a former study (measurement of pupillary light reflex already performed in that study, for the same purpose)
Who may be able to join
- age > 18 years old
- Subject without known ocular or neurological disease
- Ametropia inferior to 3 diopters for spherical correction and inferior to 1.50 diopter for astigmatism correction
- Matched for age and sex with one of the 22 subjects of the patients' unilateral NORB database
Who cannot join
- history of disease affecting pupillary motility
- anisocoria
- patient under legal protection
- pregnant or breast feeding patient
- patient's refusal to participate in the study
- no medical insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis confirmation is important to start proper treatment, because a NORB is often the first symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is difficult to define by a non-expert ophthalmologist.
The pupillary light reflex is a way to test the visual afferent pathways. If it is subject to a large inter-individual variability, the dynamics of the pupillary light reflex and its latency are more reproducible. An easy way to study the dynamics of the pupillary light reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the conduction in the visual afferent pathways related to demyelination plate increases the latency of the pupillary light reflex and decreases the frequency of the PCT.
Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease in the frequency of the PCT in NORB, compared to the frequency observed in subjects ophthalmological or neurological disease, could help developing methods to study the conduction of the visual pathways with portable devices used during the standard ophthalmologic consultation and quickly orientate patients to specialized centers.
- Conditions
- Optic Neuritis
- Being tested
- pupillary light reflex
- Keywords
- Pupillary light reflex, Multiple sclerosis
- Medical subject headings
- Optic Neuritis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pupillary light reflexDevice
measure with infra-red cameras
| Study group | Role | What they receive |
|---|---|---|
| Measure of pupillary light reflex | patients without optic neuritis Receives: Device: pupillary light reflex | |
| patients with optic neuritis | clinical database of 22 patients (measurement of pupillary light reflex already performed for the same purpose, in a former study) Receives: Device: pupillary light reflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillary cycle time
Pupillary cycle time, measured in Hertz
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJun 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Cedric Lamirel, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894281
- Sponsor's protocol ID
- CLL_2016_2
- Acronym
- PCT
- Status last verified
- Jul 2017
- First submitted
- 5 Sep 2016
- Last updated
- 7 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease
- ClinicalTrials.gov ID
- NCT02894281
- Acronym / sponsor ID
- PCT / CLL_2016_2
- Conditions
- Optic Neuritis
- Keywords
- Pupillary light reflex, Multiple sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 9 Sep 2016 (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.
Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis confirmation is important to start proper treatment, because a NORB is often the first symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is difficult to define by a non-expert ophthalmologist.
The pupillary light reflex is a way to test the visual afferent pathways. If it is subject to a large inter-individual variability, the dynamics of the pupillary light reflex and its latency are more reproducible. An easy way to study the dynamics of the pupillary light reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the conduction in the visual afferent pathways related to demyelination plate increases the latency of the pupillary light reflex and decreases the frequency of the PCT.
Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease in the frequency of the PCT in NORB, compared to the frequency observed in subjects ophthalmological or neurological disease, could help developing methods to study the conduction of the visual pathways with portable devices used during the standard ophthalmologic consultation and quickly orientate patients to specialized centers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measure of pupillary light reflex | – | Device: pupillary light reflexpatients without optic neuritis |
| patients with optic neuritis | – | Device: pupillary light reflexclinical database of 22 patients (measurement of pupillary light reflex already performed for the same purpose, in a former study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with no optic neuritis are recruited, to be compared with a database of 22 patients already recruited in a former study (measurement of pupillary light reflex already performed in that study, for the same purpose)
Key inclusion criteria (4 listed)
- age > 18 years old
- Subject without known ocular or neurological disease
- Ametropia inferior to 3 diopters for spherical correction and inferior to 1.50 diopter for astigmatism correction
- Matched for age and sex with one of the 22 subjects of the patients' unilateral NORB database
Key exclusion criteria (6 listed)
- history of disease affecting pupillary motility
- anisocoria
- patient under legal protection
- pregnant or breast feeding patient
- patient's refusal to participate in the study
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 |
|---|---|---|
| pupillary light reflexmeasure with infra-red cameras | Device | Measure of pupillary light reflex, patients with optic neuritis |
Primary outcome
pupillary cycle time
Time frame: baseline
Pupillary cycle time, measured in Hertz
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 7 Jul 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.
Cedric Lamirel, MD principal investigator
Fondation OPH A de Rothschild
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 Optic Neuritis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 4 inclusion and 6 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 7 Jul 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 France. 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?
pupillary cycle time (time frame: baseline). 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 7 Jul 2017.