NCT06692205

Brief Summary

Commonly used visual function assessments in glaucoma diagnosis and treatment-such as visual acuity, visual field, and contrast sensitivity-do not directly capture the impact of the disease on patients' daily abilities. While questionnaires can evaluate this impact from the patient's perspective, they are subject to individual biases and inconsistent evaluation standards. Thus, objective methods are needed to assess patients' abilities in visually guided daily activities. Grasping objects and avoiding obstacles are fundamental visually guided tasks that require effective visuomotor coordination. By attaching lightweight reflective markers to participants' limbs and using a motion capture system to track their movements in three-dimensional space, various indicators of planning, execution, and control in tasks such as object grasping and obstacle avoidance can be quantified, allowing for an objective evaluation of visuomotor coordination. However, it remains unclear how visuomotor coordination is affected in glaucoma patients at different disease stages or whether visual field damage in specific areas has distinct impacts on visuomotor coordination. This study, therefore, aims to investigate changes in visuomotor coordination among patients with primary open-angle glaucoma across disease stages and to determine the effects of visual field defects in different locations on their visuomotor abilities.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 21, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

November 14, 2024

Last Update Submit

November 14, 2024

Conditions

Keywords

Visual-motor coordinationglaucoma

Outcome Measures

Primary Outcomes (2)

  • Overall movement duration of the reaching-and-grasping task

    Lightweight reflective markers are attached to the participants' thumb, index finger, and wrist joints, and a motion capture system is used to track the movement of these markers in three-dimensional space. The overall movement duration during the reaching-and-grasping task is then quantified. This overall movement duration serves as an index of task execution efficiency.

    1 day (Only once)

  • Overall movement duration of the mobility task

    Lightweight reflective markers are attached to the participants' thigh, calf, and ankle joints, and a motion capture system is used to track the movement of these markers in three-dimensional space. The overall movement duration during the mobility task is then quantified, serving as an index of task execution efficiency during orientation and obstacle avoidance.

    1 day (Only once)]

Secondary Outcomes (7)

  • ETDRS visual acuity

    1 day (Only once)]

  • Automatic perimetry report

    1 day (Only once)

  • Pelli-Robson contrast sensitivity

    1 day (Only once)

  • Stereoacuity

    1 day (Only once)

  • Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40)

    1 day (Only once)

  • +2 more secondary outcomes

Study Arms (2)

Primary open-angle glaucoma

Patients with primary open-angle glaucoma diagnosed by glaucoma professionals

Healthy controls

Healthy controls were required to have a presenting Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity of 20/40 or better in both eyes.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. Primary open-angle glaucoma: patients with primary open-angle glaucoma diagnosed by glaucoma professionals 2. Healthy controls: subjects with no history of ocular disease, except for refractive errors and cataracts, and who have a presenting visual acuity of 20/40 or better in both eyes, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

You may qualify if:

  • Age between 18 and 75 years;
  • Diagnosed with primary open-angle glaucoma, with no anti-glaucoma surgery scheduled within ±1 month;
  • Best corrected visual acuity in one eye ≥ 6/12;
  • Stereoscopic vision ≥ 1000 seconds of arc;
  • Able to clearly communicate and cooperate with the completion of relevant assessments and data collection.
  • Age between 18 and 75 years;
  • No history of eye disease other than refractive error and cataract;
  • Best corrected visual acuity in both eyes ≥ 6/12;
  • Stereoscopic vision ≥ 1000 seconds of arc;
  • Able to clearly communicate and cooperate with the completion of relevant assessments and data collection.

You may not qualify if:

  • Individuals with cognitive dysfunction, psychological dysfunction, hearing impairment, or other conditions that prevent normal communication;
  • Presence of physical motor dysfunction, hyperthyroidism or hypothyroidism, malignant tumors, heart disease, or other systemic diseases;
  • Presence of other ocular conditions affecting visual function (except cataract and refractive error), such as age-related macular degeneration, diabetic retinopathy, optic neuropathy, retinal vascular disease, etc.;
  • Pregnant or lactating women.
  • Individuals with cognitive dysfunction, psychological dysfunction, hearing impairment, or other conditions that prevent normal communication;
  • Presence of physical motor dysfunction, hyperthyroidism or hypothyroidism, malignant tumors, heart disease, or other systemic diseases;
  • Presence of other ocular conditions affecting visual function (except cataract and refractive error), such as age-related macular degeneration, diabetic retinopathy, optic neuropathy, retinal vascular disease, etc.;
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Opthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (8)

  • Azoulay-Sebban L, Zhao Z, Zenouda A, Lombardi M, Gutman E, Brasnu E, Hamard P, Sahel JA, Baudouin C, Labbe A. Correlations Between Subjective Evaluation of Quality of Life, Visual Field Loss, and Performance in Simulated Activities of Daily Living in Glaucoma Patients. J Glaucoma. 2020 Oct;29(10):970-974. doi: 10.1097/IJG.0000000000001597.

    PMID: 32649451BACKGROUND
  • Corveleyn X, Lenoble Q, Rouland JF, Boucart M. What is the Nature of the Reach-and-Grasp Deficit in Glaucoma? J Glaucoma. 2020 Sep;29(9):799-806. doi: 10.1097/IJG.0000000000001555.

    PMID: 32858724BACKGROUND
  • Turano KA, Rubin GS, Quigley HA. Mobility performance in glaucoma. Invest Ophthalmol Vis Sci. 1999 Nov;40(12):2803-9.

    PMID: 10549639BACKGROUND
  • Kotecha A, O'Leary N, Melmoth D, Grant S, Crabb DP. The functional consequences of glaucoma for eye-hand coordination. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):203-13. doi: 10.1167/iovs.08-2496. Epub 2008 Sep 20.

    PMID: 18806294BACKGROUND
  • Sivaprasad S, Tschosik E, Kapre A, Varma R, Bressler NM, Kimel M, Dolan C, Silverman D. Reliability and Construct Validity of the NEI VFQ-25 in a Subset of Patients With Geographic Atrophy From the Phase 2 Mahalo Study. Am J Ophthalmol. 2018 Jun;190:1-8. doi: 10.1016/j.ajo.2018.03.006. Epub 2018 Mar 10.

    PMID: 29530781BACKGROUND
  • Ramulu PY, van Landingham SW, Massof RW, Chan ES, Ferrucci L, Friedman DS. Fear of falling and visual field loss from glaucoma. Ophthalmology. 2012 Jul;119(7):1352-8. doi: 10.1016/j.ophtha.2012.01.037. Epub 2012 Apr 4.

    PMID: 22480738BACKGROUND
  • Bambo MP, Ferrandez B, Guerri N, Fuertes I, Cameo B, Polo V, Larrosa JM, Garcia-Martin E. Evaluation of Contrast Sensitivity, Chromatic Vision, and Reading Ability in Patients with Primary Open Angle Glaucoma. J Ophthalmol. 2016;2016:7074016. doi: 10.1155/2016/7074016. Epub 2016 Oct 31.

    PMID: 27872754BACKGROUND
  • Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.

    PMID: 24974815BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 18, 2024

Study Start

November 21, 2024

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

November 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations