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Primary Open-angle GlaucomaNCT06692205

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

An observational study of Primary Open-angle Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Primary Open-angle Glaucoma
How many people
200 participants
Where
1 siteChina
Study dates
21 Nov 2024to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 1.1 Inclusion criteria of primary open-angle glaucoma group:
  • 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.
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  • 1.2 Inclusion criteria of healthy controls:
  • 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.

Who cannot join

  • 1.1 Exclusion criteria for primary open-angle glaucoma group:
  • 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.
  • 1.2 Exclusion criteria for healthy controls:
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Zhongshan Opthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Yehong Zhuo, 02066619349, zhuoyh@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Exploring the Effects of Primary Open-Angle Glaucoma on Visual-Motor Coordination

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.

Read the 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.

Keywords
Visual-motor coordination, glaucoma
Medical subject headings
Glaucoma, Open-Angle, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06692205
Study groupRoleWhat they receive
Primary open-angle glaucomaPatients with primary open-angle glaucoma diagnosed by glaucoma professionals
Healthy controlsHealthy controls were required to have a presenting Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity of 20/40 or better in both eyes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day (Only once)

  2. 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.

    Measured: 1 day (Only once)]

Secondary outcomes (7)
  1. 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.

    Measured: 1 day (Only once)]

  2. 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.

    Measured: 1 day (Only once)

  3. Pelli-Robson contrast sensitivity

    Pelli-Robson contrast sensitivity test card was used.

    Measured: 1 day (Only once)

  4. Stereoacuity

    Stereoacuity was measured using the Titmus stereopsis test.

    Measured: 1 day (Only once)

  5. 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.

    Measured: 1 day (Only once)

  6. 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.

    Measured: 1 day (Only once)

  7. 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).

    Measured: 1 day (Only once)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start21 Nov 2024 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06692205
Sponsor's protocol ID
2024KYPJ028
Status last verified
Apr 2024
First submitted
14 Nov 2024
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32649451
  • 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.

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

    PubMed 10549639
  • 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.

    PubMed 18806294
  • 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.

    PubMed 29530781
  • 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.

    PubMed 22480738
  • 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.

    PubMed 27872754
  • 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.

    PubMed 24974815

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Open-angle Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yehong Zhuo (02066619349, zhuoyh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall movement duration of the reaching-and-grasping task (time frame: 1 day (Only once)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06692205, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

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