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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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

観察的

入学 (推定)

60

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
sensitivity for contrast modulation
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Curtis L Baker, PhD、McGill University Health Centre/Research Institute of the McGill University Health Centre

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年3月1日

研究の完了 (推定)

2028年3月1日

試験登録日

最初に提出

2026年8月17日

QC基準を満たした最初の提出物

2026年8月17日

最初の投稿 (実際)

2026年8月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月20日

QC基準を満たした最後の更新が送信されました

2026年8月17日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Glaucoma test / 2026-12020
  • RGPIN-2023-03559 (その他の助成金/資金番号:Natural Sciences and Engineering Research Council of Canada)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

all IPD that underlie results in a publication

IPD 共有時間枠

when summary data are published

IPD 共有アクセス基準

open access

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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