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Glaucoma is a complex disease that can result in progressive vision loss. It is the second leading cause of blindness, accounting for 23% of permanent blindness in Hong Kong. There are no treatments that restore vision lost to glaucoma. This study will examine the effect of transcranial direct current stimulation (NIBS) on improving quality of life, visual function and functional performance in patients with peripheral field loss due to glaucoma.
This study uses a prospective, single-masked, randomized, cross-over, placebo-controlled training RCT design.
The eligible participants will be randomly allocated into 4 groups:
(A) Transcranial direct current stimulation; (B) Visual Tetanic Stimulation; (C) Transcranial direct current stimulation+ Visual Tetanic Stimulation; (D) Sham. All participants will underwent all the 4 types of intervention with a 14 days washing out period between intervention types:
All participants will complete twenty-six study visits:
Visit 1: Eligibility assessment (refer to the recruitment criteria); Visit 2: Outcome measures (Pre-intervention/ baseline); Visit 3-7: 5 sessions intervention (1st intervention block); Visit 8: Post 1 outcome measures; Visit 9-13: 5 sessions intervention (2nd intervention block); Visit 14: Post 2 outcome measures; Visit 15-19: 5 sessions intervention (3rd intervention block); Visit 20: Post 3 outcome measures; Visit 21-25: 5 sessions intervention (4th intervention block); Visit 26: Post 4 outcome measures
Eight sessions of assessment will be conducted: (1) Baseline-1; (2) Post-1 (after 5-sessions training); (3) Baseline-2; (4) Post-2 (after 5-sessions training); (5) Baseline-3; (6) Post-3 (after 5-sessions training); (7) Baseline-4; and (8) Post-4 (after 5-sessions training).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual Tetanic Stimulation (VTS) | Experimental | Participant will receive 5 training sessions with VTS: about 1 hour per session |
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| Transcranial direct current stimulation (NIBS) | Active Comparator | Participant will receive 5 training sessions with NIBS: about 1 hour per session |
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| Transcranial direct current stimulation+ Visual Tetanic Stimulation (NIBS+VTS) | Experimental | Participant will receive 5 training sessions with NIBS+VTS: about 1 hour per session |
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| Sham | Placebo Comparator | Participant will receive 5 training sessions with Sham: about 1 hour per session |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIBS | Other | Around 1 hour |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual field test | Visual field test is measured monocularly using the 24-2 Swedish interactive threshold algorithm (SITA) standard tests by Humphrey visual field analyzer (HFA, Carl Zeiss Meditec Inc., California). The mean deviation (MD), pattern standard deviation (PSD), and visual field index (VFI) are recorded, and the MD of the 24-2 visual field test will be used as the primary outcome of intervention effect. | Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention) |
| Electroencephalography (EEG) | Electrophysiological function is assessed using a 64-channel high-resolution electroencephalography (EEG) system. EEG outcome measures include spectral power in the delta, theta, alpha, beta, and gamma frequency bands, with particular focus on alpha-band activity, as well as functional connectivity measures derived from scalp EEG recordings, including coherence, phase-based connectivity, and related network indices. Pattern-reversal visual evoked potentials (PR-VEP) are recorded during presentation of a high-contrast checkerboard stimulus to the central 20-degree visual field under monocular viewing conditions. Stimuli are presented at 0.5 Hz and 1.5 Hz with 40 reversals. PR-VEP outcome measures include N75 latency, P100 latency, N135 latency, and N75-P100 and/or P100-N135 amplitude. | Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention) |
| Optical Coherence Tomography (OCT) | Retinal nerve fiber layer is measured using spectral-domain Optical Coherence Tomography (OCT). Peripapillary retinal nerve fiber layer thickness is obtained from a circular scan centered on the optic nerve head. Ganglion cell thickness is measure using macular OCT imaging | Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention) |
| Optical Coherence Tomography Angiography (OCT-A) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Yan Cheong, PhD | Contact | 852-27666108 | allen.my.cheong@polyu.edu.hk | |
| Lok Hin Chan, BSc (Hons) in Optometry | Contact | 852-34002309 | lhinchan@polyu.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
De-identified individual participant data (IPD) underlying the results reported in this study will be shared via the Open Science Framework (OSF). These data will include participant-level demographic and clinical characteristics, baseline assessments, intervention-related variables, and primary and secondary outcome data necessary to reproduce the reported analyses. Supporting documents, including the study protocol, statistical analysis plan, data dictionary, and study materials, will also be made available on OSF.
De-identified individual participant data and supporting documents will be made available beginning within 6 months after publication of the primary study results and will remain available indefinitely on the Open Science Framework (OSF).
will be publicly available
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| VTS |
| Other |
Around 1 hour |
|
| NIBS+VTS | Other | Around 1 hour |
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| Sham | Other | Around 1 hour |
|
Evaluation of retinal vascular function in glaucoma patients is measured. Detailed visualisation of microvasculature structure within the retina and optic nerve head is measured, change of ocular perfusion is shown.
| Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention) |