search
Back to results

Deficits, Adaptation and Cerebral Functional Reorganization of Visual Retinotopic Treatments During Normal and Pathological Aging (Age-related Macular Degeneration and Glaucoma) (VISIOPERICENT)

Primary Purpose

Macular Degeneration, Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Magnetic Resonance Imaging (fMRI)
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy / control participants: normal or normal corrected visual acuity
  • Patients with AMD: Diagnosis of AMD by the Clinique d'ophtalmologie of the CHU de Grenoble
  • Patients Glaucoma: Diagnosis of glaucoma by the Clinique d'ophtalmologie of the CHU de Grenoble
  • Affiliation to a social security scheme,
  • Informed consent signed,
  • Medical examination before participation in the MRI examination

Exclusion Criteria:

  • Major unprotected persons unable to express their consent,
  • Major protected,
  • Significant hearing impairment,
  • Neuropsychiatric pathology past or present (except benign epilepsy),
  • Taking narcotics and / or drugs for neurocognitive purposes,
  • Existence of a general ailment (cardiac, respiratory, haematological, renal, hepatic, cancer),
  • Other ophthalmic pathology that can affect visual function: cataract, retinal detachment

  • Contra-indication to MRI:

    1. Any subject with a vascular stent implanted less than 6 weeks before the examination.
    2. Any subject carrying implanted biomedical material judged "unsafe" or "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp.
    3. Any acquisition procedure that does not comply with the conditions required by the "conditional" use in a subject carrying implanted biomedical material considered "conditional" in the list: http://www.mrisafety.com/TheList_search. Asp.
    4. Any subject carrying an intra-ocular or intracranial ferromagnetic foreign body close to the nervous structures.
    5. Any subject with biomedical equipment such as a cardiac, neuronal or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical support trained to perform MRI in these subjects.
    6. Non-Cooperative Subject
    7. Metallic or electronic equipment incompatible with MRI examination, dental apparatus, claustrophobia, pacemaker or neurologic, non-magnetic non-magnetic vascular clip, metallic luster, diabetes
  • Pregnant women
  • Woman of childbearing age refusing to take the pregnancy test
  • Ongoing drug treatment that may affect brain activity.

Sites / Locations

  • Clinique Ophtalmologique Universitaire de Grenoble

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cerebral Bases of Central and Peripheral Visual Integration

Arm Description

Outcomes

Primary Outcome Measures

Accuracy of visual tasks in relation to the intensity of cerebral activity measured in fMRI
Measurement of cerebral activity during visual tasks

Secondary Outcome Measures

Full Information

First Posted
April 24, 2017
Last Updated
December 26, 2019
Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition
search

1. Study Identification

Unique Protocol Identification Number
NCT03133117
Brief Title
Deficits, Adaptation and Cerebral Functional Reorganization of Visual Retinotopic Treatments During Normal and Pathological Aging (Age-related Macular Degeneration and Glaucoma)
Acronym
VISIOPERICENT
Official Title
Deficits, Adaptation and Cerebral Functional Reorganization of Visual Retinotopic Treatments During Normal and Pathological Aging (Age-related Macular Degeneration and Glaucoma)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
not enough patients
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
May 25, 2018 (Actual)
Study Completion Date
May 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition

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
The main objective of this research is to study the cognitive and cerebral mechanisms of the integration of central and peripheral visual information during normal and pathological aging (ophthalmological patients with AMD and glaucoma) through fMRI studies. To assess the effect of normal aging, research will be conducted on a group of young participants with normal vision and a group of elderly participants with normal vision. Each participant will be assessed once during an MRI (during which the brain activity and behavioral performance will be measured). In order to evaluate the effect of pathological aging, research will be conducted on AMD patients, glaucomatous patients, and age-matched controls (normal vision), evaluated only once during an MRI examination.
Detailed Description
Healthy / control participants with normal vision will be volunteers, selected after interview (inclusion assessment). Their recruitment will be carried out on the basis of advertisements displayed at Grenoble Alpes University. Patients will be volunteers, selected on the basis of their ophthalmological clinical record. Their recruitment will be done at the Ophthalmology Clinic of the University Hospital of Grenoble (through Professor Florent Aptel). For all the participants, a medical examination before MRI examination will be carried out in the MRU unit of the CHU of Grenoble in order to verify the eligibility criteria for contraindications to MRI and MRI scanning. The results of these examinations will be communicated to the subjects prior to the expression of their consent directly or through the doctor of their choice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Glaucoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebral Bases of Central and Peripheral Visual Integration
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Functional Magnetic Resonance Imaging (fMRI)
Intervention Description
Functional Magnetic Resonance Imaging (fMRI)
Primary Outcome Measure Information:
Title
Accuracy of visual tasks in relation to the intensity of cerebral activity measured in fMRI
Description
Measurement of cerebral activity during visual tasks
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy / control participants: normal or normal corrected visual acuity Patients with AMD: Diagnosis of AMD by the Clinique d'ophtalmologie of the CHU de Grenoble Patients Glaucoma: Diagnosis of glaucoma by the Clinique d'ophtalmologie of the CHU de Grenoble Affiliation to a social security scheme, Informed consent signed, Medical examination before participation in the MRI examination Exclusion Criteria: Major unprotected persons unable to express their consent, Major protected, Significant hearing impairment, Neuropsychiatric pathology past or present (except benign epilepsy), Taking narcotics and / or drugs for neurocognitive purposes, Existence of a general ailment (cardiac, respiratory, haematological, renal, hepatic, cancer), Other ophthalmic pathology that can affect visual function: cataract, retinal detachment Contra-indication to MRI: Any subject with a vascular stent implanted less than 6 weeks before the examination. Any subject carrying implanted biomedical material judged "unsafe" or "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp. Any acquisition procedure that does not comply with the conditions required by the "conditional" use in a subject carrying implanted biomedical material considered "conditional" in the list: http://www.mrisafety.com/TheList_search. Asp. Any subject carrying an intra-ocular or intracranial ferromagnetic foreign body close to the nervous structures. Any subject with biomedical equipment such as a cardiac, neuronal or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical support trained to perform MRI in these subjects. Non-Cooperative Subject Metallic or electronic equipment incompatible with MRI examination, dental apparatus, claustrophobia, pacemaker or neurologic, non-magnetic non-magnetic vascular clip, metallic luster, diabetes Pregnant women Woman of childbearing age refusing to take the pregnancy test Ongoing drug treatment that may affect brain activity.
Facility Information:
Facility Name
Clinique Ophtalmologique Universitaire de Grenoble
City
Grenoble Cedex 9
State/Province
CHU Albert Michallon - CS 10217
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Learn more about this trial

Deficits, Adaptation and Cerebral Functional Reorganization of Visual Retinotopic Treatments During Normal and Pathological Aging (Age-related Macular Degeneration and Glaucoma)

We'll reach out to this number within 24 hrs