An observational study in Primary Open-angle Glaucoma, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational
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.
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 200 is above the median of 103 across 454 observational studies indexed under Glaucoma.
Browse Glaucoma studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.
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Inclusion Criteria:
1.1 Inclusion criteria of primary open-angle glaucoma group:
1.2 Inclusion criteria of healthy controls：
Exclusion Criteria:
1.1 Exclusion criteria for primary open-angle glaucoma group:
1.2 Exclusion criteria for healthy controls：
Patients with primary open-angle glaucoma diagnosed by glaucoma professionals
Healthy controls were required to have a presenting Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity of 20/40 or better in both eyes.
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.
Time frame: 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.
Time frame: 1 day (Only once)]
ETDRS visual acuity
The information of Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity was obtained from the hospital electronic medical record system or outpatient medical record data.
Time frame: 1 day (Only once)]
Automatic perimetry report
Automatic perimetry reports were obtained from the hospital electronic medical record system or outpatient medical record data. Mean defect (MD), mode standard deviation (PSD), corrected mode standard deviation (CPSD), short-term fluctuation (SF), glaucoma half field analysis (GHT), paracentric scotoma, nasal staircase, arch scotoma, tubular field and other characteristic visual field defects were recorded.
Time frame: 1 day (Only once)
Pelli-Robson contrast sensitivity
Pelli-Robson contrast sensitivity test card was used.
Time frame: 1 day (Only once)
Stereoacuity
Stereoacuity was measured using the Titmus stereopsis test.
Time frame: 1 day (Only once)
Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40)
Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40) is a 40-item questionnaire developed to evaluate the visual ability of glaucoma patients in detail. It consists of 40 items and measures the impact of glaucoma on restriction of participation in daily activities in five domains of functioning. Each item has six answer options, that is, no difficulty (score = 1), mild difficulty (score = 2), moderate difficulty (score = 3), extremely difficult (score = 4), completely unable to complete (score = 5), and do not perform for nonvisual reasons (no score). The GVFQ-40 is administered by a trained interviewer to all enrolled participants.
Time frame: 1 day (Only once)
National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25)
The National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) is a valid and reliable vision-related quality of life (QOL) questionnaire designed for persons who have chronic eye diseases or low vision. It includes 25 items that comprise 11 subscales on different aspects of vision-related functioning and QOL and 1 item on general health. NEI VFQ-25 scores range from 0 to 100, with a higher score representing better functioning.
Time frame: 1 day (Only once)
Short form 36 health survey questionnaire (SF-36)
The Short Form 36 Health Survey Questionnaire (SF-36) is an instrument designed to measure health perception in a general population. It consists of 36 items and typically takes about five minutes to complete. The questionnaire assesses health across eight multi-item dimensions, covering functional status, well-being, and overall health evaluation. In six of the eight dimensions, patients are asked to rate their responses on three- or six-point scales. For each dimension, item scores are coded, summed, and transformed onto a scale ranging from 0 (worst health) to 100 (best health).
Time frame: 1 day (Only once)
Plan to share: No
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Zhongshan Ophthalmic Center, Sun Yat-sen University