University Health Network/ Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Location status: Recruiting
NCT Number: NCT07409077
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.
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Interventional
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Toronto, Ontario, M5T 2S8, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Visual Biofeedback Training
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Quality of Life using the MAssof 48 questions validated questionnaire
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
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Measured with the MP3 MICROPERIMETER
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Measured with the Colenbrander charts at 100% contrast in ETDRS logMAR.
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Measured with the MNRead App
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Measured with the VCTS charts.
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Measured with the Nidek MP3 microperimeter
University Health Network, Toronto
Other
Efficacy of Biofeedback Training for Visual Function and Quality of Life in Glaucoma: A Randomized Controlled Trial
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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.
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