Vision DisordersPlainteIMFNCT02529098
Modification in Cortical Activation in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation
A study testing fMRI in people with Vision Disorders, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study will highlight differences in cortical activation between asymptomatic and symptomatic patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Disorders
- What is being tested?
- fMRI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jul 2016
- 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
- Cataract surgery with an bilateral multifocal lens implant Restor
- Symptomatic patients :
- Symptomatic bilateral visual difficulties for 3 months or more after the intervention which impact the daily activity
- Asymptomatic patients :
- No visual complaint for 3 months or more after the intervention
Who cannot join
- Patients with ophthalmology disorders
- Contra indication for fMRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modification in Cortical Activation by Functional Magnetic Resonance Imaging (fMRI) in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation
This study will highlight differences in cortical activation between asymptomatic and symptomatic patients.
- Conditions
- Vision Disorders
- Being tested
- fMRI
- Keywords
- functional magnetic resonance imaging, Lens implantation, pseudophakia
- Medical subject headings
- Vision Disorders, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
functional magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic patients | Sham comparator | fMRI Asymptomatic patients Receives: Other: fMRI |
| symptomatic patients | Experimental | fMRI patients with visual difficulties Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of neural activation in visual cortex measured by the number of voxels
compare the extent of neural activation in visual cortex between groups
Measured: 1 day
Secondary outcomes (1)
extent of neural activation in visual cortex measured by the number of voxels
compare the extent of neural activation in the different area visual cortex between groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: default recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisordersStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Malecaze, professor, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529098
- Sponsor's protocol ID
- 12 523 03
- Acronym
- PlainteIMF
- Status last verified
- May 2016
- First submitted
- 10 Jun 2015
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification in Cortical Activation by Functional Magnetic Resonance Imaging (fMRI) in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation
- ClinicalTrials.gov ID
- NCT02529098
- Acronym / sponsor ID
- PlainteIMF / 12 523 03
- Conditions
- Vision Disorders
- Keywords
- functional magnetic resonance imaging, Lens implantation, pseudophakia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: default recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- 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.
This study will highlight differences in cortical activation between asymptomatic and symptomatic patients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asymptomatic patients | Sham comparator | Other: fMRIfMRI Asymptomatic patients |
| symptomatic patients | Experimental | Other: fMRIfMRI patients with visual difficulties |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cataract surgery with an bilateral multifocal lens implant Restor
- Symptomatic bilateral visual difficulties for 3 months or more after the intervention which impact the daily activity
- No visual complaint for 3 months or more after the intervention
Key exclusion criteria (2 listed)
- Patients with ophthalmology disorders
- Contra indication for fMRI
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 |
|---|---|---|
| fMRIfunctional magnetic resonance imaging | Other | asymptomatic patients, symptomatic patients |
Primary outcome
Extent of neural activation in visual cortex measured by the number of voxels
Time frame: 1 day
compare the extent of neural activation in visual cortex between groups
1 secondary outcome
extent of neural activation in visual cortex measured by the number of voxels
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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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.
Francois Malecaze, professor principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Vision Disorders, run by University Hospital, Toulouse 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 1 Jun 2016. 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.
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?
Extent of neural activation in visual cortex measured by the number of voxels (time frame: 1 day). 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 1 Jun 2016.