Macular DegenerationVISIOPERICENTNCT03133117
Deficits, Adaptation and Cerebral Functional Reorganization of Visual Retinotopic Treatments During Normal and Pathological Aging (Age-related Macular Degeneration and Glaucoma)
A study testing Functional Magnetic Resonance Imaging (fMRI) in people with Macular Degeneration and Glaucoma, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration, Glaucoma
- What is being tested?
- Functional Magnetic Resonance Imaging (fMRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2017to 25 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Clinique Ophtalmologique Universitaire de Grenoble
Grenoble, CHU Albert Michallon - CS 10217, 38043
About this study
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.
Read the 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.
- Conditions
- Macular Degeneration, Glaucoma
- Being tested
- Functional Magnetic Resonance Imaging (fMRI)
- Medical subject headings
- Macular Degeneration, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance Imaging (fMRI)Radiation
Functional Magnetic Resonance Imaging (fMRI)
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Bases of Central and Peripheral Visual Integration | Experimental | Not described Receives: Radiation: Functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of visual tasks in relation to the intensity of cerebral activity measured in fMRI
Measurement of cerebral activity during visual tasks
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start2 Feb 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133117
- Sponsor's protocol ID
- 38RC16.070
- Acronym
- VISIOPERICENT
- Status last verified
- Dec 2019
- First submitted
- 24 Apr 2017
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deficits, Adaptation and Cerebral Functional Reorganization of Visual Retinotopic Treatments During Normal and Pathological Aging (Age-related Macular Degeneration and Glaucoma)
- ClinicalTrials.gov ID
- NCT03133117
- Acronym / sponsor ID
- VISIOPERICENT / 38RC16.070
- Conditions
- Macular Degeneration, Glaucoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Bases of Central and Peripheral Visual Integration | Experimental | Radiation: Functional Magnetic Resonance Imaging (fMRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (18 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI)Functional Magnetic Resonance Imaging (fMRI) | Radiation | Cerebral Bases of Central and Peripheral Visual Integration |
Primary outcome
Accuracy of visual tasks in relation to the intensity of cerebral activity measured in fMRI
Time frame: One hour
Measurement of cerebral activity during visual tasks
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Resonance Imaging (fMRI) in people with Macular Degeneration and Glaucoma, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of visual tasks in relation to the intensity of cerebral activity measured in fMRI (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.