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Macular DegenerationNCT04685824

Visual Telerehabilitation in AMD Patients

A study testing Biofeedback Training and Immersive Virtual-Reality in people with Macular Degeneration, run by Michael Reber at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Following the degeneration of the macula and the loss of central vision, the patients naturally relocate the fixation point for high visual acuity peripherally, in an eccentric and healthy part of the retina (PRL), to compensate for visual impairments. Read more about this study

Who is it for?
Any age
Conditions the study is for
Macular Degeneration
What is being tested?
Biofeedback Training and Immersive Virtual-Reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteCanada
Study dates
15 Sep 2021to 6 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • Dry-AMD.
  • BCVA > 20/160.
  • Ability to follow the visual and auditory stimuli and training instructions.
  • Auditory test positive at 50Hz 25-60dBHL.
  • Home Wi-Fi access.

Who cannot join

  • Wet AMD.
  • Both eyes with media opacity that impairs microperimetry testing.
  • Inability to perform during testing and training.
  • Psychoactive drugs consumption.
  • 3 consecutive VRISE scores < 25 at inclusion.
  • History of vertigo or dizziness
  • Prior vision rehabilitation interventions.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Krembil Research Institute/Toronto Western Hospital

    Toronto, Ontario, M5T 0S8

Other trials in Canada

About this study

Official title: Visual Rehabilitation in Macular Degeneration: a Pilot Study on Biofeedback Training and Home-based Mobile Virtual-reality Stimulation

Following the degeneration of the macula and the loss of central vision, the patients naturally relocate the fixation point for high visual acuity peripherally, in an eccentric and healthy part of the retina (PRL), to compensate for visual impairments. However, in many cases, the PRL lands on a sub-optimal retinal area and becomes useless. Modern low-vision rehabilitation procedures for AMD patients include biofeedback training (BFT) to relocate the PRL to a healthy retinal patch and acquire better fixation skills. This study seeks to combine BFT with home-based immersive virtual-reality audiovisual stimulation and measure feasibility and potential effectiveness on oculomotor control and visual perception.

Being tested
Biofeedback Training, Immersive Virtual-Reality
Keywords
Visual rehabilitation, Oculus Go, Virtual-reality, Biofeedback
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biofeedback TrainingDevice

    Audiovisual stimulation

  • Immersive Virtual-RealityDevice

    Audiovisual stimulation

Study groups in NCT04685824
Study groupRoleWhat they receive
Biofeedback TrainingActive comparator* Biofeedback training (BFT): 1 sessions of 4 x 20 minutes blocks. Rest time of 5 minutes between blocks. 1 session per week for 4 weeks (4 sessions total). * 30 min daily reading at home for 4 weeks.
Receives: Device: Biofeedback Training
Biofeedback Training + Immersive VRExperimental* Biofeedback training (BFT) [1 sessions of 4 x 20 minutes blocks. Rest time of 5 minutes between blocks], 1 session per week for 4 weeks (4 sessions total). * 30 min daily reading at home for 4 weeks * Immersive virtual-reality stimulation (IVR) [1 session of 3 blocks of 15 trials of 20 seconds each. Rest time is 1-2 minute(s) between blocks], 1 session every 2 days for 4 weeks (14 sessions total).
Receives: Device: Biofeedback Training; Device: Immersive Virtual-Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of home-based IVR audiovisual stimulation

    Feasibility objectives for our pilot study to be considered successful:

    1. Number of patients completing the stimulation protocol: ≥ 13 out of 16 patients (81%) per group.
    2. Number of IVR sessions performed by the patients to consider the stimulation protocol complete: ≥ 13 sessions out of 16 (81%).
    3. Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores < 25: ≤ 3 per patient during the treatment period.
    4. Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): ≤ 3 (19%) during the treatment period.
    5. Number of randomized patients per week: ≥ 3 patients.

    Measured: 18 months

Secondary outcomes (6)

  1. Visual Acuity

    Change from baseline at 4 weeks, 1 month and 6 months:

    • Best Corrected Visual Acuity, distance and near vision (range 20/12.5 to <20/1000, higher score = better outcome)

    Measured: from baseline to end of follow-up at 7 months

  2. Retinal Sensitivity

    Change from baseline at 4 weeks,1 month and 6 months:

    • Mean retinal sensitivity (Macular Integrity Assessment, MAIA microperimetry - score: 0 dB to 36 dB, higher score = better outcome)

    Measured: from baseline to end of follow-up at 7 months

  3. Fixation stability

    Change from baseline at 4 weeks,1 month and 6 months:

    • Mean fixation stability (Macular Integrity Assessment, MAIA microperimetry - range 0.02 sq.deg. to 40.0 sq.deg., lowest score = better outcome)

    Measured: from baseline to end of follow-up at 7 months

  4. Contrast Sensitivity

    Change from baseline at 4 weeks, 1 month and 6 months:

    • Mean contrast sensitivity (Functional Acuity Contrast Test, FACT - range 0.48 cyc./deg. to 2.41 cyc./deg., higher score = better outcome)

    Measured: from baseline to end of follow-up at 7 months

  5. Reading Speed

    Change from baseline at 4 weeks,1 month and 6 months:

    • Mean reading speed (Minnesota Low Vision Reading test, MNREAD - range 0 word/minute to 280 word/minute, higher score = better outcome)

    Measured: from baseline to end of follow-up at 7 months

  6. Quality of Life Scores

    Change from baseline at 4 weeks,1 month and 6 months:

    • Quality of life scores (Veteran's Affairs Low Vision Questionnaire, VA-LVQ 48 - range -31.5 to +26.6, higher score = better outcome)

    Measured: from baseline to end of follow-up at 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start15 Sep 2021
  3. Primary completion6 Oct 2023
  4. Study completion6 Oct 2023

Why it stopped: Recruitment rate not reached.

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685824
Sponsor's protocol ID
2020410013068
Status last verified
Nov 2023
First submitted
15 Dec 2020
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biofeedback Training and Immersive Virtual-Reality in people with Macular Degeneration, run by Michael Reber 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Nov 2023. 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?

The study was stopped early (reason given: Recruitment rate not reached.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of home-based IVR audiovisual stimulation (time frame: 18 months). 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 NCT04685824.

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 30 Nov 2023.

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Visual Telerehabilitation in AMD Patients | AzTrials