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

NCT03464357 | Unknown

• 2 other identifiers: RC31/17/02752017-A02601-52
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome; Photophobia

Keywords

functional MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  One day

Study Arms (2)

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

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

Radiation: fMRI

Interventions

fMRI RADIATION

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.

Asymptomatic patient; Symptomatic patients with dry eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Photophobia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• François Malecaze, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Malecaze, MD

CONTACT

5 61 77 77 52; malecaze.fr@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

5 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: March 13, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)