- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02862405
Perception of Objects and Natural Scenes in People With Vision Loss (ACTIVIS) (ACTIVIS)
8. august 2016 opdateret af: Lille Catholic University
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.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
260
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with eye disease causing loss of central or peripheral vision
Beskrivelse
Inclusion Criteria cases:
- Patients with eye disease causing loss of central or peripheral vision
- French speakers
- Age between 18 and 90 years old
- Written consent
- Health insurance
Inclusion Criteria controls:
- Sex and age matched controls (+/- 5 years)
- French speakers
- Normal visual examination with visual acuity of min 9/10
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
|
|
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.
|
|
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Control group
Patients without loss of vision.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of performances in visual tests between different groups according to error rate
Tidsramme: 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.
|
at inclusion
|
|
Comparison of performances in visual tests between different groups according to answer time
Tidsramme: 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.
|
at inclusion
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Estimation of the score of visual acuity by the logMAR chart
Tidsramme: at inclusion
|
at inclusion
|
|
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Measure of lesion size
Tidsramme: at inclusion
|
at inclusion
|
|
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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)
Tidsramme: 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.
|
at inclusion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thi Ha Chau Tran, MD, Hospital of the Lille Catholic Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2011
Primær færdiggørelse (Faktiske)
1. marts 2015
Studieafslutning (Faktiske)
1. marts 2015
Datoer for studieregistrering
Først indsendt
2. august 2016
Først indsendt, der opfyldte QC-kriterier
8. august 2016
Først opslået (Skøn)
11. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RC-P009
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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