Vision LossACTIVISNCT02862405
Perception of Objects and Natural Scenes in People With Vision Loss (ACTIVIS)
An observational study of Vision Loss, run by Lille Catholic University.
Trial summary
The loss of central vision causes difficulty not only in reading but also in faces recognition, and in particular in the identification of facial expression, objects or spaces. These visual deficits have been mainly studied in relation with reading, which is the main complaint of these kind of patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Loss
- What is being tested?
- vision tests
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2015
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with eye disease causing loss of central or peripheral vision
Who may be able to join
- Patients with eye disease causing loss of central or peripheral vision
- French speakers
- Age between 18 and 90 years old
- Written consent
- Health insurance
- Sex and age matched controls (+/- 5 years)
- French speakers
- Normal visual examination with visual acuity of min 9/10
Who cannot join
- Psychiatric disease or neurological pathologies
- Communication difficulties (deafness / mutism)
- Drug treatment altering concentration
- Mental deterioration with MMS <24
- Alcoholism or addiction to drugs
- Persons under guardianship
About this study
Official title: Evaluation of the Perception of Objects and Natural Scenes in People With Vision Loss (Loss of Central or Peripheral Vision)
The loss of central vision causes difficulty not only in reading but also in faces recognition, and in particular in the identification of facial expression, objects or spaces. These visual deficits have been mainly studied in relation with reading, which is the main complaint of these kind of patients. However, there are not enough data regarding perception of objects and spaces in this population. Then, the objectives are to study the visual-spatial abilities in individuals with vision loss, and altered cognitive processes, (2) to develop clinics tools for early detection and quantification of visual-spatial deficits and (3)to understand the capacities of normal peripheral vision in order to test the possibility of potential training for use of peripheral vision when central vision is impaired by an ophthalmic pathology.
- Conditions
- Vision Loss
- Being tested
- vision tests
- Keywords
- Vision loss, Object recognition, Space recognition
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vision testsOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with loss of central vision | Patients coming in ophthalmic consultation will be selected for the study. The diagnosis of this disease is based on clinical examination, and imaging of the retina.Patients with only loss of central vision will be selected. Receives: Other: vision tests | |
| Patients with loss of peripheral vision | Patients coming in ophthalmic consultation will be selected for the study. Patients with loss of peripheral vision will be selected on the bases of presence of tunnel vision. Receives: Other: vision tests | |
| Control group | Patients without loss of vision. Receives: Other: vision tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of performances in visual tests between different groups according to error rate
These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.
Measured: at inclusion
Comparison of performances in visual tests between different groups according to answer time
These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.
Measured: at inclusion
Secondary outcomes (3)
Estimation of the score of visual acuity by the logMAR chart
Measured: at inclusion
Measure of lesion size
Measured: at inclusion
Pearson correlation coefficient to determine the correlation between the performance parameters during visual tests (error rate and answer time) and clinical parameters (visual acuity and lesion size)
These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMar 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision LossStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Thi Ha Chau Tran, MD, Principal investigator, Hospital of the Lille Catholic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862405
- Sponsor's protocol ID
- RC-P009
- Acronym
- ACTIVIS
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Perception of Objects and Natural Scenes in People With Vision Loss (Loss of Central or Peripheral Vision)
- ClinicalTrials.gov ID
- NCT02862405
- Acronym / sponsor ID
- ACTIVIS / RC-P009
- Conditions
- Vision Loss
- Keywords
- Vision loss, Object recognition, Space recognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Aug 2016 (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.
The loss of central vision causes difficulty not only in reading but also in faces recognition, and in particular in the identification of facial expression, objects or spaces. These visual deficits have been mainly studied in relation with reading, which is the main complaint of these kind of patients. However, there are not enough data regarding perception of objects and spaces in this population. Then, the objectives are to study the visual-spatial abilities in individuals with vision loss, and altered cognitive processes, (2) to develop clinics tools for early detection and quantification of visual-spatial deficits and (3)to understand the capacities of normal peripheral vision in order to test the possibility of potential training for use of peripheral vision when central vision is impaired by an ophthalmic pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with loss of central vision | – | Other: vision testsPatients coming in ophthalmic consultation will be selected for the study. The diagnosis of this disease is based on clinical examination, and imaging of the retina.Patients with only loss of central vision will be selected. |
| Patients with loss of peripheral vision | – | Other: vision testsPatients coming in ophthalmic consultation will be selected for the study. Patients with loss of peripheral vision will be selected on the bases of presence of tunnel vision. |
| Control group | – | Other: vision testsPatients without loss of vision. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with eye disease causing loss of central or peripheral vision
Key inclusion criteria (8 listed)
- Patients with eye disease causing loss of central or peripheral vision
- French speakers
- Age between 18 and 90 years old
- Written consent
- Health insurance
Key exclusion criteria (6 listed)
- Psychiatric disease or neurological pathologies
- Communication difficulties (deafness / mutism)
- Drug treatment altering concentration
- Mental deterioration with MMS <24
- Alcoholism or addiction to drugs
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 |
|---|---|---|
| vision tests | Other | Control group, Patients with loss of central vision, Patients with loss of peripheral vision |
Primary outcome
Comparison of performances in visual tests between different groups according to error rate
Time frame: at inclusion
These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.
Comparison of performances in visual tests between different groups according to answer time
Time frame: at inclusion
These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.
3 secondary outcomes
Estimation of the score of visual acuity by the logMAR chart
Time frame: at inclusion
Measure of lesion size
Time frame: at inclusion
Pearson correlation coefficient to determine the correlation between the performance parameters during visual tests (error rate and answer time) and clinical parameters (visual acuity and lesion size)
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Thi Ha Chau Tran, MD principal investigator
Hospital of the Lille Catholic Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Vision Loss, run by Lille Catholic University.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of performances in visual tests between different groups according to error rate (time frame: at inclusion). The study lists 2 primary outcomes in all. 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 11 Aug 2016.