NCT07409077

Brief 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, 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Jun 2028

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 3, 2026

Last Update Submit

February 10, 2026

Conditions

GlaucomaBiofeedback Training

Keywords

glaucomabiofeedback training

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Near Vision

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

  • Reading speed

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

  • Contrast Sensitivity

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

  • Retinal Sensitivity

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

Study Arms (2)

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.

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.

Other: Biofeedback Training

Interventions

Biofeedback TrainingOTHER

Visual Biofeedback Training

Biofeedback Training (BT)Control (Delayed Biofeedback Training)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network/ Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 13, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

CA(1)