GlaucomaNCT07409077
Efficacy of Biofeedback Training for Glaucoma
A study testing Biofeedback Training in people with Glaucoma and Biofeedback Training, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Biofeedback Training
- What is being tested?
- Biofeedback Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network/ Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Monica Daibert-Nido, MD, 416-603-5470, monica.nido@uhn.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma, Biofeedback Training
- Being tested
- Biofeedback Training
- Keywords
- glaucoma, biofeedback training
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback TrainingOther
Visual Biofeedback Training
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Training (BT) | Experimental | 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. Receives: Other: Biofeedback Training |
| Control (Delayed Biofeedback Training) | Active comparator | 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. Receives: Other: Biofeedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire
Quality of Life using the MAssof 48 questions validated questionnaire
Measured: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Visual acuity
Distance visual acuity measured with ETDRS charts at 4 meters
Measured: Baseline and follow-up visits at 9 weeks, 6 months, 1 year, and 2 years post-intervention
Fixation Stability
Measured with the MP3 MICROPERIMETER
Measured: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Secondary outcomes (4)
Near Vision
Measured with the Colenbrander charts at 100% contrast in ETDRS logMAR.
Measured: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Reading speed
Measured with the MNRead App
Measured: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Contrast Sensitivity
Measured with the VCTS charts.
Measured: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Retinal Sensitivity
Measured with the Nidek MP3 microperimeter
Measured: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Feb 2026
- Primary completion30 Jan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Daibert Nido, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409077
- Sponsor's protocol ID
- 23-5650
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biofeedback Training for Visual Function and Quality of Life in Glaucoma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07409077
- Acronym / sponsor ID
- 23-5650
- Conditions
- Glaucoma, Biofeedback Training
- Keywords
- glaucoma, biofeedback training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Training (BT) | Experimental | Other: Biofeedback TrainingParticipants 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. |
| Control (Delayed Biofeedback Training) | Active comparator | Other: Biofeedback TrainingParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback TrainingVisual Biofeedback Training | Other | Biofeedback Training (BT), Control (Delayed Biofeedback Training) |
Primary outcome
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
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
Fixation Stability
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Measured with the MP3 MICROPERIMETER
4 secondary outcomes
Near Vision
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Reading speed
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Contrast Sensitivity
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Retinal Sensitivity
Time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- BackgroundK. 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
- Individual participant dataSharing planned: Undecided
Related trials for Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Training in people with Glaucoma and Biofeedback Training, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire (time frame: Baseline, 9 weeks, 6 months, 1 year and 2 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07409077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.