Effects of Primary Open-angle Glaucoma on Visual-motor Coordination

NCT ID: NCT06692205

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-21
• Study Completion Date: 2025-12-31

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.

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide, with an estimated 110 million glaucoma patients expected globally among individuals aged 40-80 by 2040. As a chronic and progressive eye disease, glaucoma can cause significant impairments in visual function. These impairments can severely limit daily activities like searching, walking, and reading, leading to a significant decline in patients' vision-related quality of life. Evaluating the visual abilities of glaucoma patients can not only gauge the extent of the disease's impact on their visual function but also indicate the effectiveness of clinical treatments and rehabilitation strategies. However, commonly used clinical tests, such as visual acuity and visual field, only partially reflect visual function and do not directly measure the disease's impact on daily activities. Questionnaires can be designed to assess the impact of the disease on daily activities, from the patient's perspective. However, as a subjective assessment method, questionnaires are susceptible to individual biases and evaluation standards. Therefore, more objective methods are needed to evaluate patients' performance and abilities in executing daily visually guided activities.

Grasping objects and avoiding obstacles are fundamental visually guided activities that require good visuomotor coordination. The visual system supplies essential information about the spatial position and intrinsic properties of objects, while the brain integrates this information to guide and control limb movements for specific tasks. By attaching lightweight reflective markers, such as spheres or patches, to participants' limbs and using a motion capture system to track these markers in three-dimensional space, various indicators of planning, execution, and control during tasks can be quantified. This approach enables an objective assessment of participants' visuomotor coordination abilities.

Previous studies have shown that glaucoma patients differ from age-matched healthy controls in reaching-grasping tasks, though findings on these differences have been inconsistent. Furthermore, researchers have reported that glaucoma patients also face challenges with mobility. However, it remains unclear how visuomotor coordination in glaucoma patients is affected across different disease stages during tasks like object grasping and obstacle avoidance, or whether the location of visual field damage has varied effects on their visuomotor coordination. In this study, we aim to compare the performance of patients with primary open-angle glaucoma and age-matched healthy controls in reaching-grasping and mobility tasks. Our goal is to investigate changes in visuomotor coordination across different stages of the disease and to clarify how visual field defects in various locations impact patients' visuomotor abilities.

Conditions

Primary Open-angle Glaucoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Primary open-angle glaucoma

Patients with primary open-angle glaucoma diagnosed by glaucoma professionals

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 75 years;

2. Diagnosed with primary open-angle glaucoma, with no anti-glaucoma surgery scheduled within ±1 month;

3. Best corrected visual acuity in one eye ≥ 6/12;

4. Stereoscopic vision ≥ 1000 seconds of arc;

5. Able to clearly communicate and cooperate with the completion of relevant assessments and data collection.

1. Age between 18 and 75 years;

2. No history of eye disease other than refractive error and cataract;

3. Best corrected visual acuity in both eyes ≥ 6/12;

4. Stereoscopic vision ≥ 1000 seconds of arc;

5. Able to clearly communicate and cooperate with the completion of relevant assessments and data collection.

Exclusion Criteria

1. Individuals with cognitive dysfunction, psychological dysfunction, hearing impairment, or other conditions that prevent normal communication;

2. Presence of physical motor dysfunction, hyperthyroidism or hypothyroidism, malignant tumors, heart disease, or other systemic diseases;

3. 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.;

4. Pregnant or lactating women.

1. Individuals with cognitive dysfunction, psychological dysfunction, hearing impairment, or other conditions that prevent normal communication;

2. Presence of physical motor dysfunction, hyperthyroidism or hypothyroidism, malignant tumors, heart disease, or other systemic diseases;

3. 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.;

4. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Opthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yehong Zhuo

Role: CONTACT

zhuoyh@mail.sysu.edu.cn

02066619349

Haishun Huang

Role: CONTACT

huanghsh9@mail2.sysu.edu.cn

13229518626

Facility Contacts

Yehong Zhuo

Role: primary

zhuoyh@mail.sysu.edu.cn

02066619349

References

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.

Reference Type: BACKGROUND

PMID: 32649451 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32858724 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10549639 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18806294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29530781 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22480738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27872754 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24974815 (View on PubMed)

Other Identifiers

2024KYPJ028

Identifier Type: -

Identifier Source: org_study_id