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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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