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Functional MRI Study of Cortical Modifications to Light Stimulation in Patients With Photophobia

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03464357
Enrollment
16
Registered
2018-03-14
Start date
2018-03-13
Completion date
2019-03-31
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome, Photophobia

Keywords

functional MRI

Brief 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.

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).

Interventions

RADIATIONfMRI

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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The spatial extent of activation of the visual cortexOne dayMeasurement 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.

Countries

France

Contacts

Primary ContactFrançois Malecaze, MD
malecaze.fr@chu-toulouse.fr5 61 77 77 52
Backup ContactIsabelle Olivier, PhD
olivier.i@chu-toulouse.fr5 61 77 70 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026