- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07775898
Behavioural Test for Early Glaucoma
Development of a Behavioural Test for Early Glaucoma
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
The experiments will evaluate motion perception using our previously developed contrast-modulated (CM) stimulus which seems to reveal functionality of the Y-like retinal ganglion cells (RGCs) most affected in early glaucoma (Ramirez et al., 2022). We will compare performance across glaucomatous vs. preserved regions (as indicated by conventional clinical tests) within the visual field of the affected eye(s) of the glaucoma patient group, and corresponding regions of eyes of the healthy control group. A limited number of patients (10-30) will be referred by Dr. Hady Saheb, a glaucoma specialist at the MUHC, who will provide relevant clinical background, i.e., age, relevant medical history, and recent Standard Automated Perimetry (SAP) and OCT (optical coherence tomography) results. Dr. Saheb will selectively refer individuals with early-stage primary open-angle glaucoma (POAG) ("preperimetric" glaucoma).
Participants with normal vision will be recruited from McGill Vision Research group members, former consenting participants, or the local community, primarily through direct contact by the experimenters.
Participants will undergo a preliminary interview during their first study visit. This interview will be to obtain information about date of birth, past and present health status, and medical history (relevant to vision and ophthalmic conditions). They will also participate in a preliminary evaluation of their visual function, with standard visual acuity (reading letters on a Snellen acuity chart). Information such as date of birth, past and present general health status will be self-reported by participants while other information related to specific ophthalmic conditions and/or treatments may be completed with the assistance of the glaucoma specialist.
For participants who meet the eligibility criteria, human psychophysical methods will be used to measure their performance on behavioural tasks. Psychophysical testing will be conducted in the CIM in L3 of the Montreal General Hospital. Participants will be comfortably seated and view visual stimuli presented on a computer-controlled display screen, while they maintain their gaze on a provided fixation target. During testing, one eye will be covered with a patch, so that stimuli are viewed monocularly. Each trial will consist of a brief stimulus presentation during which the participant provides a response. Trials will be organized into blocks lasting 5-10 minutes. Several such blocks will make up a session (of no more than one hour), with rest periods in between the trial blocks. In these trials, contrast modulation (CM) stimuli will be briefly displayed, and participants will indicate their perception by pressing keyboard keys, moving a mouse, or moving their eyes. For example, participants will indicate the perceived direction of motion, or the presence of a visual stimulus versus a blank screen. In some experiments the participant's eye movements will be monitored by a camera and recorded while they view the visual images (only the pattern of the eye movements is recorded, images of the participant's face are not recorded). The eye movement monitoring will provide on-line assessment of whether the participant's gaze is directed to the fixation target - or in some cases, as a behavioural response to the visual stimuli. Correct responses on the behavioural task may be indicated to the participant on each trial. Participants are encouraged to request a break or a rest at any time they desire during a session. Depending on the participant's willingness and comfortability, they may be invited to participate in an additional session as part of the same visit. The computer will collect and store the relevant data (stimulus conditions, button presses, eye movements, mouse movements) for all the trial blocks, for subsequent data analysis.
A series of familiarization trials will be provided, for each participant to verify their understanding and become comfortable with the behavioural task, using stimulus parameters designed to make the task relatively easy, at least for their unaffected eye, or for unaffected parts of the visual field of the glaucomtous eye. Participants who are able to perform the behavioural task in their unaffected visual fields will then be invited to participate in at least one additional visit, for systematic comparison of their glaucomatous vs unaffected visual field regions. In these initial study visits, we will employ the CM stimulus and task of reporting its motion direction (Ramirez et al., 2022).
For participants willing to continue with further study visits, we may undertake more thorough, systematic perimetry with our CM stimulus/task, or exploratory studies with alternative versions of the stimulus and/or task which might be easier for the patients.
Study visits will each be no more than 2 hours. Participants will be financially compensated at the rate of $20/hour.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Ana L Ramirez, MSc
- Puhelinnumero: 34819 514-394-1934
- Sähköposti: ana.ramirezhernandez@mail.mcgill.ca
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Glaucoma patients: Adults suffering from early-stage glaucoma with no other history of other medical conditions that affect standard behavioural or morphological tests for glaucoma.
Adults with healthy/normal vision: Healthy adults, recruited from members of lab groups within McGill Vision Research (including students and staff members), former research participants, and/or from within the local community.
Exclusion Criteria:
- Corrected visual acuity lower than 20/40 as measured with Snellen chart; previous medical, ocular or neurological diseases or deficiencies other than glaucoma (e.g., epilepsy, macular degeneration, developmental dyslexia) that negatively affect visual task performance.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
glaucoma patients
Adults suffering from early-stage glaucoma with no other history of other medical conditions that affect standard behavioural or morphological tests for glaucoma
|
|
healthy adults
adults with healthy/normal vision
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
sensitivity for contrast modulation
Aikaikkuna: two visits of about two hours each
|
Contrast sensitivity for detecting direction of motion of a contrast-modulated visual stimulus
|
two visits of about two hours each
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Curtis L Baker, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Glaucoma test / 2026-12020
- RGPIN-2023-03559 (Muu apuraha/rahoitusnumero: Natural Sciences and Engineering Research Council of Canada)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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