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Behavioural Test for Early Glaucoma

Development of a Behavioural Test for Early Glaucoma

Glaucoma-related blindness often results from delayed diagnosis, largely due to the disease's gradual onset, it's early manifestation predominantly in peripheral vision, and the limited sensitivity of current detection methods for its early stages (Stein et al., 2021). This project aims to determine whether early functional loss can be identified using a novel psychophysical task based on perception of contrast-modulated visual stimuli, which reflects the functionality of the retinal neurons thought to be earliest affected in glaucoma (Ramirez et al., 2022). As a proof of concept, this preliminary study will explore both the feasibility and the diagnostic sensitivity and specificity of this approach. Task performance will be compared between areas of the visual field classified by standard clinical testing as affected or unaffected by glaucoma. Psychophysical testing will take place at the Centre for Innovative Medicine (CIM) using computer-based tasks administered to patients with early-stage glaucoma, as well as healthy controls.

研究概览

地位

尚未招聘

详细说明

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.

研究类型

观察性的

注册 (估计的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Glaucoma patients: referral from ophthalmologist who is a co-investigator Adults with healthy/normal vision: 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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
sensitivity for contrast modulation
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Curtis L Baker, PhD、McGill University Health Centre/Research Institute of the McGill University Health Centre

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2026年8月17日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Glaucoma test / 2026-12020
  • RGPIN-2023-03559 (其他赠款/资助编号:Natural Sciences and Engineering Research Council of Canada)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

all IPD that underlie results in a publication

IPD 共享时间框架

when summary data are published

IPD 共享访问标准

open access

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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