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Glaucoma Rehabilitation Using ElectricAI Transcranial Stimulation (GREAT) - Randomized Controlled Trial Using Combined Perceptual Learning and Transcranial Electrical Stimulation for Vision Enhancement

Glaucoma Clinical Trial

Official title:
Improving Vision and Quality of Life in Patients With Glaucoma Using Non-invasive Brain Stimulation and Perceptual Learning: A Randomized Clinical Trial

Clinical Trial Summary

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. However, recent studies have shown that vision can be improved by perceptual learning (PL) and transcranial electrical stimulation (tES). This study will examine the effect of perceptual learning and tES on improving quality of life, visual function and functional performance in patients with peripheral field loss due to glaucoma. It is phase 2 of Glaucoma Rehabilitation Using ElectricAI Transcranial Stimulation (GREAT) project.

Clinical Trial Description

Study design: This study uses a prospective, double-masked, randomized, placebo-controlled training RCT design. The eligible participants will be randomly allocated into 3 groups: (A) Placebo-Perceptual learning + Sham-tES; (B) Real-Perceptual learning + Sham-tES; (C) Real-Perceptual learning + Real-tES. All participants will complete forty-three study visits: Visit 1: Eligibility assessment (refer to the recruitment criteria); Visit 2-3: Outcome measures (Pre-intervention/ baseline); Visit 4-13: 10 sessions intervention (1st batch); Visit 14-15: Interim 1 Outcome measures; Visit 16-25: 10 sessions intervention (2nd batch); Visit 26-27: Interim 2 Outcome measures; Visit 28-37: 10 sessions intervention (3rd batch); Visit 38-39: Post-training 1 Outcome measures; Visit 40-41: Post-training 2 Outcome measures (to evaluate the retention effect after 1 month); Visit 42-43: Post-training 3 Outcome measures (to evaluate the retention effect after 2 months). Six sessions of assessment will be conducted: (1) Baseline; (2) Interim-1 (after 10-sessions training); (3) Interim-2 (after 20-sessions training); (4) Post-1 (after 30-sessions training); (5) Post-2 (1-month post training); and (6) Post-3 (2-month post training). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05874258
Study type Interventional
Source The Hong Kong Polytechnic University
Contact Allen Cheong, PhD
Phone 852-27666108
Email allen.my.cheong@polyu.edu.hk
Status Recruiting
Phase N/A
Start date May 15, 2023
Completion date December 31, 2025
View Details
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