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

NCT03133117 | Terminated

• 1 other identifier: 38RC16.070
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration; Glaucoma

Outcome Measures

Primary Outcomes (1)

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

  Measurement of cerebral activity during visual tasks

  One hour

Study Arms (1)

Cerebral Bases of Central and Peripheral Visual Integration

EXPERIMENTAL

Radiation: Functional Magnetic Resonance Imaging (fMRI)

Interventions

Functional Magnetic Resonance Imaging (fMRI) RADIATION

Functional Magnetic Resonance Imaging (fMRI)

Cerebral Bases of Central and Peripheral Visual Integration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire de Psychologie et NeuroCognition: collaborator

Study Sites (1)

Clinique Ophtalmologique Universitaire de Grenoble

Grenoble, CHU Albert Michallon - CS 10217, 38043, France

Location

MeSH Terms

Conditions

Macular Degeneration; Glaucoma

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Ocular Hypertension

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 28, 2017
• Study Start: February 2, 2017
• Primary Completion: May 25, 2018
• Study Completion: May 25, 2018
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

FR (1)