70 Participants Needed

Biofeedback Training for Glaucoma

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this 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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-95 with glaucoma, specifically those who have stable eye pressure and paracentral scotomata (blind spots) near the center of their vision. Participants must be able to follow instructions for biofeedback training.

Inclusion Criteria

Presence of paracentral scotomata within two degrees of fixation
Ability to follow instructions for biofeedback training
I am between 18 and 95 years old.
See 1 more

Exclusion Criteria

Inability to perform study assessments or follow instructions for biofeedback training
I have received treatment for low vision.
I have severe eye conditions not related to glaucoma.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group undergo five weekly sessions of biofeedback training, each lasting approximately 20 minutes

5 weeks
5 visits (in-person)

Control Period

Participants in the control group receive standard clinical assessments without biofeedback training

9 weeks
1 visit (in-person)

Follow-up

Participants are monitored for visual function and quality of life at scheduled follow-up visits

2 years
Follow-up visits at 9 weeks, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Biofeedback Training

Trial Overview

The study tests if visual biofeedback training can improve eye movement control and use of remaining vision in people with glaucoma. Half the participants will receive this training while the other half won't, to compare outcomes like visual stability and quality of life.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Biofeedback Training (BT)Experimental Treatment1 Intervention
Group II: Control (Delayed Biofeedback Training)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+