Efficacy of Biofeedback Training for Glaucoma

Efficacy of Biofeedback Training for Visual Function and Quality of Life in Glaucoma: A Randomized Controlled Trial

This randomized controlled clinical trial evaluates the efficacy of visual biofeedback training on visual function and quality of life in individuals with glaucoma. Glaucoma is a progressive optic neuropathy that can lead to irreversible vision loss, including impaired fixation stability, reduced retinal sensitivity, and decreased functional vision. Biofeedback training is a visual rehabilitation technique designed to help patients improve fixation stability and optimize use of remaining visual function by training eye movements toward retinal areas with better sensitivity.

Seventy participants with glaucoma will be randomized to either a biofeedback training intervention group or a control group. Visual function outcomes, including fixation stability, retinal sensitivity, visual acuity, reading speed, contrast sensitivity, and quality of life, will be assessed at baseline and follow-up visits. This study aims to determine whether biofeedback training can improve visual function and quality of life in patients with glaucoma.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Biofeedback Training
• Intervention / Treatment: Other: Biofeedback Training

Detailed Description

Glaucoma is a leading cause of irreversible blindness worldwide and is characterized by progressive damage to the optic nerve, resulting in visual field loss, impaired fixation stability, and reduced retinal sensitivity. In advanced stages, patients may develop unstable or eccentric fixation, leading to significant functional visual impairment and reduced quality of life. Current glaucoma treatments primarily aim to control intraocular pressure and do not address the rehabilitation of visual function once damage has occurred.

This prospective, randomized controlled trial is designed to evaluate the efficacy of visual biofeedback training (BT) as a rehabilitation strategy for improving visual function and quality of life in individuals with glaucoma. Biofeedback training is a non-invasive intervention that uses visual and auditory feedback to guide participants in directing their eye movements toward a preferred retinal locus with better sensitivity and stability, thereby optimizing the use of residual vision.

A total of 70 participants with a prior diagnosis of glaucoma will be enrolled and randomized in a 1:1 ratio to either the biofeedback training group (n=35) or a control group (n=35). Participants in the intervention group will undergo five weekly sessions of biofeedback training, each lasting approximately 20 minutes. Participants in the control group will receive standard clinical assessments and will be offered biofeedback training after completion of the control period.

Primary outcome measures include fixation stability and retinal sensitivity assessed using microperimetry, best-corrected visual acuity for distance and near vision, reading speed, and vision-related quality of life. Secondary outcome measures include preferred retinal locus characteristics, contrast sensitivity, oculomotor function (saccades and smooth pursuit), visual field testing, and optical coherence tomography parameters.

Assessments will be conducted at baseline and at follow-up visits, including 9 weeks, 6 months, 1 year, and up to 2 years post-intervention for the treatment group. Data analysis will be conducted using an intention-to-treat approach. This study seeks to determine whether visual biofeedback training can improve functional vision and quality of life in individuals with glaucoma and to explore whether treatment effects vary by age and baseline retinal sensitivity.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • University Health Network/ Toronto Western Hospital
      • Contact: Monica Daibert-Nido, MD; Phone Number: 416-603-5470; Email: monica.nido@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-95 years old.
• Glaucoma cases with adequate intraocular pressure control.
• Presence of paracentral scotomata within two degrees of fixation.
• Ability to follow instructions for biofeedback training.

Exclusion Criteria:

• Prior or current low vision rehabilitation treatment.
• Ocular diseases or severe clinical conditions unrelated to glaucoma
• Media opacities that prevent reliable microperimetry testing in both eyes.
• Inability to perform study assessments or follow instructions for biofeedback training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback Training (BT); Participants randomized to this arm will receive visual biofeedback training in addition to standard clinical care. The intervention consists of five weekly in-office training sessions, each lasting approximately 20 minutes. During training, participants are guided using visual and auditory feedback to direct eye movements toward a preferred retinal locus with better retinal sensitivity and fixation stability. Visual function and quality of life assessments will be conducted at baseline and at scheduled follow-up visits.	Other: Biofeedback Training; Visual Biofeedback Training
Active Comparator: Control (Delayed Biofeedback Training); Participants randomized to this arm will undergo standard clinical assessments without biofeedback training during the initial study period. Visual function and quality of life assessments will be conducted at baseline and at the 9-week follow-up visit. After completion of the control period, participants will be offered biofeedback training as part of standard clinical care.	Other: Biofeedback Training; Visual Biofeedback Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire	Quality of Life using the MAssof 48 questions validated questionnaire	Baseline, 9 weeks, 6 months, 1 year and 2 years.
Visual acuity	Distance visual acuity measured with ETDRS charts at 4 meters	Baseline and follow-up visits at 9 weeks, 6 months, 1 year, and 2 years post-intervention
Fixation Stability	Measured with the MP3 MICROPERIMETER	Baseline, 9 weeks, 6 months, 1 year and 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Vision	Measured with the Colenbrander charts at 100% contrast in ETDRS logMAR.	Baseline, 9 weeks, 6 months, 1 year and 2 years.
Reading speed	Measured with the MNRead App	Baseline, 9 weeks, 6 months, 1 year and 2 years.
Contrast Sensitivity	Measured with the VCTS charts.	Baseline, 9 weeks, 6 months, 1 year and 2 years.
Retinal Sensitivity	Measured with the Nidek MP3 microperimeter	Baseline, 9 weeks, 6 months, 1 year and 2 years.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Publications and helpful links

General Publications

• K. Schuster A, Erb C, M. Hoffmann E, Dietlein T, Pfeiffer N. The Diagnosis and Treatment of Glaucoma. Dtsch Ärztebl Int. 2020 Mar;117(13):225-34. 2. Kang JM, Tanna AP. Glaucoma. Med Clin North Am. 2021 May;105(3):493-510. 3. Vingolo EM, Casillo L, Mecarelli G, Limoli PG. Rehabilitative strategies after filtering procedure in glaucoma. Sci Rep. 2022 Oct 7;12(1):16877. 4. 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 1;121(11):2081-90. 5. Tomairek RH, Aboud SA, Hassan M, Mohamed AH. Studying the role of 10-2 visual field test in different stages of glaucoma. Eur J Ophthalmol. 2020 Jul;30(4):706-13. 6. Kameda T, Tanabe T, Hangai M, Ojima T, Aikawa H, Yoshimura N. Fixation behavior in advanced stage glaucoma assessed by the MicroPerimeter MP-1. Jpn J Ophthalmol. 2009 Nov;53(6):580-7. 7. Verboschi F, Domanico D, Nebbioso M, Corradetti G, Zaccaria Scalinci S, Vingolo EM. New trends in visual rehabilitation with MP-1 microperimeter biofeedback: optic neural dysfunction. Funct Neurol. 2013;28(4):285-91. 8. Quaranta L, Riva I, Gerardi C, Oddone F, Floriano I, Konstas AGP. Quality of Life in Glaucoma: A Review of the Literature. Adv Ther. 2016;33(6):959-81. 9. Wilson MR, Coleman AL, Yu F, Bing EG, Sasaki IF, Berlin K, et al. Functional status and well-being in patients with glaucoma as measured by the Medical Outcomes Study Short Form-36 questionnaire. Ophthalmology. 1998 Nov;105(11):2112-6. 10.Nguyen M. The cost of vision loss and blindness in Canada. 11.Misawa M, Pyatova Y, Sen A, Markowitz M, Markowitz SN, Reber M, et al. Innovative vision rehabilitation method for hemianopsia: Comparing pre- and post audio-luminous biofeedback training for ocular motility improving visual functions and quality of life. Front Neurol. 2023;14:1151736. 12.Daibert-Nido M, Pyatova Y, Markowitz M, Taheri-Shirazi M, Markowitz SN. Post audio-visual

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: glaucoma; biofeedback training
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 23-5650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No