NCT05874258

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Glaucoma

Interventions

Type	Name	Description
OTHER	Real-PL training + Real-tES(tDCS)	PLtraining : around 40mins, tDCS: 20mins
OTHER	Real-PL training + Sham-tES (tDCS)	PL training : around 40mins, tDCS: 20mins
OTHER	Placebo-PL training + Sham-tES (tDCS)	PL training : around 40mins, tDCS: 20mins

Timeline

• Start date: 2023-05-15
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2023-05-24
• Last updated: 2024-10-29

Locations

1 site across 1 country: Hong Kong