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

Primary Purpose

Dry Eye Syndrome, Photophobia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dry Eye Syndrome focused on measuring functional MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Symptomatic patients with dry eye

Asymptomatic patient

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2018
Last Updated
April 16, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03464357
Brief Title
Functional MRI Study of Cortical Modifications to Light Stimulation in Patients With Photophobia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Photophobia
Keywords
functional MRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic patients with dry eye
Arm Type
Active Comparator
Arm Description
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
Arm Title
Asymptomatic patient
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
fMRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
The spatial extent of activation of the visual cortex
Description
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.
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Malecaze, MD
Phone
5 61 77 77 52
Ext
33
Email
malecaze.fr@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Olivier, PhD
Phone
5 61 77 70 51
Ext
33
Email
olivier.i@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Malecaze, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Malecaze, MD
Phone
5 61 77 77 52
Ext
33
Email
malecaze.fr@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Isabelle Olivier, PhD
Phone
5 61 77 70 51
Ext
33
Email
olivier.i@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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