Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07409077

Efficacy of Biofeedback Training for Glaucoma

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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network/ Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Monica Daibert-Nido, MD

CONTACT

[email protected]

416-603-5470

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biofeedback training

Other

Visual Biofeedback Training

Primary outcomes

  1. Quality of Life Questionnaire

    Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.

    Quality of Life using the MAssof 48 questions validated questionnaire

  2. Visual acuity

    Time frame: Baseline and follow-up visits at 9 weeks, 6 months, 1 year, and 2 years post-intervention

    Distance visual acuity measured with ETDRS charts at 4 meters

  3. Fixation Stability

    Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.

    Measured with the MP3 MICROPERIMETER

Secondary outcomes

  1. Near Vision

    Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.

    Measured with the Colenbrander charts at 100% contrast in ETDRS logMAR.

  2. Reading speed

    Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.

    Measured with the MNRead App

  3. Contrast Sensitivity

    Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.

    Measured with the VCTS charts.

  4. Retinal Sensitivity

    Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.

    Measured with the Nidek MP3 microperimeter

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.