Efficacy of Biofeedback Training for Glaucoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Health Network, Toronto

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Biofeedback Training

    Other intervention

    Visual Biofeedback Training

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Biofeedback Training (BT)Experimental treatment 1 intervention
Group B: Control (Delayed Biofeedback Training)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Life Questionnaire

Quality of Life using the MAssof 48 questions validated questionnaire

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

Visual acuity

Distance visual acuity measured with ETDRS charts at 4 meters

Time frame
Baseline and follow-up visits at 9 weeks, 6 months, 1 year, and 2 years post-intervention
3

Fixation Stability

Measured with the MP3 MICROPERIMETER

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

Secondary outcomes

1

Near Vision

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

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

Reading speed

Measured with the MNRead App

Time frame
Baseline, 9 weeks, 6 months, 1 year and 2 years.
3

Contrast Sensitivity

Measured with the VCTS charts.

Time frame
Baseline, 9 weeks, 6 months, 1 year and 2 years.
4

Retinal Sensitivity

Measured with the Nidek MP3 microperimeter

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

Other outcomes

Sponsors and contacts

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