Dry Eye SyndromeNCT03464357
Functional MRI Study of Cortical Modifications to Light Stimulation in Patients With Photophobia
A study testing fMRI in people with Dry Eye Syndrome and Photophobia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Photophobia is a common and disabling symptom in patient with dry eye syndrome. The aim of this study is tried to better understand this complain analyzing brain activation during a luminous stimulation to highlight modification of cortical activation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome, Photophobia
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2018to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic subjects : presence of bilateral photophobia with an impact on daily activities (driving, outdoor activities, screens use, socio-professional activities…) in a context of patent dry eye syndrome
- Asymptomatic subjects : no dry eye syndrome and no photophobia
- Patients able to understand medical information and sign consent.
Who cannot join
- Ophthalmological pathologies of cornea, iris, optic nerve or retina
- MRI contraindications (metallic prosthesis, pacemaker, claustrophobia)
- Neurological pathology which may affect MRI results
- Subjects under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
François Malecaze, MD, 5 61 77 77 52 ext. 33, malecaze.fr@chu-toulouse.fr
Isabelle Olivier, PhD, 5 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Official title: Modification of Cortical Activation After Luminous Stimulation in Functional Magnetic Resonance Imaging (MRI) in Patients With Photophobia Related to Moderate to Acute Dry Eye Syndrome.
Photophobia is a common and disabling symptom in patient with dry eye syndrome. The aim of this study is tried to better understand this complain analyzing brain activation during a luminous stimulation to highlight modification of cortical activation.
Read the detailed description
Dry eye syndrome is a frequent and underestimated disease whose incidence tends to increase because of the population ageing and behaviors modification (time spent using screens increased, wearing of contact lenses…). Photophobia deteriorates the quality of life in patients with dry eye syndrome decreasing outdoor activities. This symptom is not understood and does not seem to be linked with dry eye syndrome severity. The study will compare cortical activation after luminous stimulation of 16 patients eyes (8 patients with dry eye syndrome and photophobia vs 8 asymptomatic patients) using functional MRI (fMRI).
The primary study endpoint was the extent of magnetic signals in visual cortex after luminous stimulation. Secondary endpoints were the spatial activation extent in the 3 areas of the visual cortex (Brodmann areas 17,18,19).
- Conditions
- Dry Eye Syndrome, Photophobia
- Being tested
- fMRI
- Keywords
- functional MRI
- Medical subject headings
- Dry Eye Syndromes, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIRadiation
The BOLD (Blood-Oxygen-Level Dependent) signal obtained by fMRI reflects the rate of oxygenation of the blood in the brain. However, the hemodynamic response that corresponds to an inflow of oxygenated blood increases in regions that consume energy. Thus, it is possible, by the study of the BOLD signal, to know with a great precision the regions of the brain specially active during a given task.
The recorded signals reflect a neuronal activation. For each eye, recordings with and without flash visual stimulation are performed alternately.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic patients with dry eye | Active comparator | 8 symptomatic patients with dry eye (mild to severe) assessed using a validated questionnaire (OSDI score, Appendix 1) associated with a disabling photophobia (need to wear sunglasses permanently outside, restriction of the outputs in case of significant brightness, restriction of the use of the screens because of the visual embarrassment ...). The fMRI will be carried out following the inclusion visit after all the necessary checks Receives: Radiation: fMRI |
| Asymptomatic patient | Active comparator | 8 asymptomatic patients presenting neither photophobia (even minimal) or dry eye.
The fMRI will be carried out following the inclusion visit after all the necessary checks Receives: Radiation: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The spatial extent of activation of the visual cortex
Measurement of voxel activation is validated and standardized (SPM8 software (Wellcome Department of Cognitive Neurology, London, UK) . In order to be able to determine the anatomical location of the voxels, a registration of the images on the standard image MNI152 (Montreal National Institute) provided by the Montreal Neurological Institute for which the spatial location of all the areas is known will be realized. It will thus be obtained, the number of activated voxels per visual area (Brodmann 17, 18, 19) for each hemisphere (contralateral and ipsilateral) of a subject with or without complaint.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start13 Mar 2018
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will compare the extent of neuronal activation at the visual cerebral cortex between a group with photophobia related to dry eye syndrome and a group of asymptomatic patients (without dry eye and no photophobia) with an MRIf.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Malecaze, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464357
- Sponsor's protocol ID
- RC31/17/0275
- Other IDs
- 2017-A02601-52
- Status last verified
- Apr 2018
- First submitted
- 7 Mar 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Cortical Activation After Luminous Stimulation in Functional Magnetic Resonance Imaging (MRI) in Patients With Photophobia Related to Moderate to Acute Dry Eye Syndrome.
- ClinicalTrials.gov ID
- NCT03464357
- Acronym / sponsor ID
- RC31/17/0275
- Conditions
- Dry Eye Syndrome, Photophobia
- Keywords
- functional MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 14 Mar 2018 (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.
Photophobia is a common and disabling symptom in patient with dry eye syndrome. The aim of this study is tried to better understand this complain analyzing brain activation during a luminous stimulation to highlight modification of cortical activation.
Detailed description
Dry eye syndrome is a frequent and underestimated disease whose incidence tends to increase because of the population ageing and behaviors modification (time spent using screens increased, wearing of contact lenses…). Photophobia deteriorates the quality of life in patients with dry eye syndrome decreasing outdoor activities. This symptom is not understood and does not seem to be linked with dry eye syndrome severity. The study will compare cortical activation after luminous stimulation of 16 patients eyes (8 patients with dry eye syndrome and photophobia vs 8 asymptomatic patients) using functional MRI (fMRI).
The primary study endpoint was the extent of magnetic signals in visual cortex after luminous stimulation. Secondary endpoints were the spatial activation extent in the 3 areas of the visual cortex (Brodmann areas 17,18,19).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will compare the extent of neuronal activation at the visual cerebral cortex between a group with photophobia related to dry eye syndrome and a group of asymptomatic patients (without dry eye and no photophobia) with an MRIf.
| Arm | Type | Receives |
|---|---|---|
| Symptomatic patients with dry eye | Active comparator | Radiation: fMRI8 symptomatic patients with dry eye (mild to severe) assessed using a validated questionnaire (OSDI score, Appendix 1) associated with a disabling photophobia (need to wear sunglasses permanently outside, restriction of the outputs in case of significant brightness, restriction of the use of the screens because of the visual embarrassment ...). The fMRI will be carried out following the inclusion visit after all the necessary checks |
| Asymptomatic patient | Active comparator | Radiation: fMRI8 asymptomatic patients presenting neither photophobia (even minimal) or dry eye. The fMRI will be carried out following the inclusion visit after all the necessary checks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic subjects : presence of bilateral photophobia with an impact on daily activities (driving, outdoor activities, screens use, socio-professional activities…) in a context of patent dry eye syndrome
- Asymptomatic subjects : no dry eye syndrome and no photophobia
- Patients able to understand medical information and sign consent.
Key exclusion criteria (4 listed)
- Ophthalmological pathologies of cornea, iris, optic nerve or retina
- MRI contraindications (metallic prosthesis, pacemaker, claustrophobia)
- Neurological pathology which may affect MRI results
- Subjects under legal protection
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 |
|---|---|---|
| fMRIThe BOLD (Blood-Oxygen-Level Dependent) signal obtained by fMRI reflects the rate of oxygenation of the blood in the brain. However, the hemodynamic response that corresponds to an inflow of oxygenated blood increases in regions that consume energy. Thus, it is possible, by the study of the BOLD signal, to know with a great precision the regions of the brain specially active during a given task. The recorded signals reflect a neuronal activation. For each eye, recordings with and without flash visual stimulation are performed alternately. | Radiation | Asymptomatic patient, Symptomatic patients with dry eye |
Primary outcome
The spatial extent of activation of the visual cortex
Time frame: One day
Measurement of voxel activation is validated and standardized (SPM8 software (Wellcome Department of Cognitive Neurology, London, UK) . In order to be able to determine the anatomical location of the voxels, a registration of the images on the standard image MNI152 (Montreal National Institute) provided by the Montreal Neurological Institute for which the spatial location of all the areas is known will be realized. It will thus be obtained, the number of activated voxels per visual area (Brodmann 17, 18, 19) for each hemisphere (contralateral and ipsilateral) of a subject with or without complaint.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Syndrome
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
François Malecaze, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Dry Eye Syndrome and Photophobia, run by University Hospital, Toulouse 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 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Malecaze, MD (5 61 77 77 52 ext. 33, malecaze.fr@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The spatial extent of activation of the visual cortex (time frame: One day). 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 18 Apr 2018.