Visual Telerehabilitation in AMD Patients

November 27, 2023 updated by: Michael Reber

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 0S8
        • Krembil Research Institute/Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Biofeedback Training
  • 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.
Device: Biofeedback Training
Audiovisual stimulation
Experimental: Biofeedback Training + Immersive VR
  • 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).
Device: Biofeedback Training
Audiovisual stimulation
Device: Immersive Virtual-Reality
Audiovisual stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of home-based IVR audiovisual stimulation
Time Frame: 18 months

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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: from baseline to end of follow-up at 7 months

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)
from baseline to end of follow-up at 7 months
Retinal Sensitivity
Time Frame: from baseline to end of follow-up at 7 months

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)
from baseline to end of follow-up at 7 months
Fixation stability
Time Frame: from baseline to end of follow-up at 7 months

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)
from baseline to end of follow-up at 7 months
Contrast Sensitivity
Time Frame: from baseline to end of follow-up at 7 months

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)
from baseline to end of follow-up at 7 months
Reading Speed
Time Frame: from baseline to end of follow-up at 7 months

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)
from baseline to end of follow-up at 7 months
Quality of Life Scores
Time Frame: from baseline to end of follow-up at 7 months

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)
from baseline to end of follow-up at 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Reber

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

October 6, 2023

Study Completion (Actual)

October 6, 2023

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020410013068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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