Central or Peripheral Visual ImpairmentBEHAVENCT03505398
Study of Visual-spatial Attention by Eye Tracking as a Function of Central or Peripheral Visual Impairment
A study testing microperimetry, visual acuity and automated visual field in people with Central or Peripheral Visual Impairment, run by Nantes University Hospital at 1 site in France.
Trial summary
The objective of this pilot work is to determine the role of central and peripheral visions in explicit attention processes (saccade planning) in the case of visual impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central or Peripheral Visual Impairment
- What is being tested?
- microperimetry, visual acuity and automated visual field
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2018to 20 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years;
- Patient with a central visual deficit (central scotoma on the visual field: DMLA, cones dystrophy ...) or peripheral (annular scotoma: chronic glaucoma, retinitis pigmentosa ...) or without visual deficit (corrected visual acuity and visual field)
- Patient agreeing to participate in the study and signing informed consent
- Patient affiliated to social security
Who cannot join
- Pregnant woman
- Patient with known epilepsy
- Major under judicial safeguard, or deprived of liberty
- Major under guardianship or curatorship or admitted to a health or social institution for purposes other than research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Visual-spatial Attention by Oculomotor Recording (Eye Tracking) as a Function of Central or Peripheral Visual Impairment
The objective of this pilot work is to determine the role of central and peripheral visions in explicit attention processes (saccade planning) in the case of visual impairment.
- Conditions
- Central or Peripheral Visual Impairment
- Being tested
- microperimetry, visual acuity, automated visual field, eye movements recording
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microperimetryProcedure or surgery
define the retinal fixation point and the differential sensitivity threshold of the retina.
visual acuityProcedure or surgery
using ETDRS scales
automated visual fieldProcedure or surgery
recording visual attention based on central or peripheral visual information
eye movements recordingProcedure or surgery
recording of explicit visual attention based on central or peripheral visual information
| Study group | Role | What they receive |
|---|---|---|
| central vision disorder | Experimental | Not described Receives: Procedure: microperimetry; Procedure: visual acuity; Procedure: automated visual field; Procedure: eye movements recording |
| peripheral vision disorder | Experimental | Not described Receives: Procedure: microperimetry; Procedure: visual acuity; Procedure: automated visual field; Procedure: eye movements recording |
| control | Other | Not described Receives: Procedure: microperimetry; Procedure: visual acuity; Procedure: automated visual field; Procedure: eye movements recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of visual acuity (central versus peripheral)
Measured: Day 0
Microperimetry recording (central versus peripheral)
Measured: Day 0
recording of automated visual field (central versus peripheral)
Measured: Day 0
recording of eye movements (central versus peripheral)
Measured: Day 0
Secondary outcomes (4)
Measurement of visual acuity (patient versus control)
Measured: Day 0
Microperimetry recording (patient versus control)
Measured: Day 0
recording of automated visual field (patient versus control)
Measured: Day 0
recording of eye movements (patient versus control)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start15 May 2018
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Why it stopped: Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central or Peripheral Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505398
- Sponsor's protocol ID
- RC17_0134
- Other IDs
- 2017-A00977-46
- Acronym
- BEHAVE
- Status last verified
- Jan 2024
- First submitted
- 27 Mar 2018
- Last updated
- 1 Feb 2024
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Visual-spatial Attention by Oculomotor Recording (Eye Tracking) as a Function of Central or Peripheral Visual Impairment
- ClinicalTrials.gov ID
- NCT03505398
- Acronym / sponsor ID
- BEHAVE / RC17_0134
- Conditions
- Central or Peripheral Visual Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 23 Apr 2018 (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 objective of this pilot work is to determine the role of central and peripheral visions in explicit attention processes (saccade planning) in the case of visual impairment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| central vision disorder | Experimental | Procedure: microperimetry, Procedure: visual acuity, Procedure: automated visual field, Procedure: eye movements recording |
| peripheral vision disorder | Experimental | Procedure: microperimetry, Procedure: visual acuity, Procedure: automated visual field, Procedure: eye movements recording |
| control | Other | Procedure: microperimetry, Procedure: visual acuity, Procedure: automated visual field, Procedure: eye movements recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18 years;
- Patient with a central visual deficit (central scotoma on the visual field: DMLA, cones dystrophy ...) or peripheral (annular scotoma: chronic glaucoma, retinitis pigmentosa ...) or without visual deficit (corrected visual acuity and visual field)
- Patient agreeing to participate in the study and signing informed consent
- Patient affiliated to social security
Key exclusion criteria (4 listed)
- Pregnant woman
- Patient with known epilepsy
- Major under judicial safeguard, or deprived of liberty
- Major under guardianship or curatorship or admitted to a health or social institution for purposes other than research.
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 |
|---|---|---|
| microperimetrydefine the retinal fixation point and the differential sensitivity threshold of the retina. | Procedure or surgery | central vision disorder, control, peripheral vision disorder |
| visual acuityusing ETDRS scales | Procedure or surgery | central vision disorder, control, peripheral vision disorder |
| automated visual fieldrecording visual attention based on central or peripheral visual information | Procedure or surgery | central vision disorder, control, peripheral vision disorder |
| eye movements recordingrecording of explicit visual attention based on central or peripheral visual information | Procedure or surgery | central vision disorder, control, peripheral vision disorder |
Primary outcome
Measurement of visual acuity (central versus peripheral)
Time frame: Day 0
Microperimetry recording (central versus peripheral)
Time frame: Day 0
recording of automated visual field (central versus peripheral)
Time frame: Day 0
recording of eye movements (central versus peripheral)
Time frame: Day 0
4 secondary outcomes
Measurement of visual acuity (patient versus control)
Time frame: Day 0
Microperimetry recording (patient versus control)
Time frame: Day 0
recording of automated visual field (patient versus control)
Time frame: Day 0
recording of eye movements (patient versus control)
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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 microperimetry, visual acuity and automated visual field in people with Central or Peripheral Visual Impairment, run by Nantes University Hospital 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 4 inclusion and 4 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 1 Feb 2024. 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: Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available). 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?
Measurement of visual acuity (central versus peripheral) (time frame: Day 0). The study lists 4 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 1 Feb 2024.