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Visual Telerehabilitation in AMD Patients

Primary Purpose

Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Biofeedback Training
Immersive Virtual-Reality
Sponsored by
Michael Reber
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Macular Degeneration focused on measuring Visual rehabilitation, Oculus Go, Virtual-reality, Biofeedback

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Krembil Research Institute/Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Biofeedback Training

Biofeedback Training + Immersive VR

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Feasibility of home-based IVR audiovisual stimulation
Feasibility objectives for our pilot study to be considered successful: Number of patients completing the stimulation protocol: ≥ 13 out of 16 patients (81%) per group. Number of IVR sessions performed by the patients to consider the stimulation protocol complete: ≥ 13 sessions out of 16 (81%). Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores < 25: ≤ 3 per patient during the treatment period. Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): ≤ 3 (19%) during the treatment period. Number of randomized patients per week: ≥ 3 patients.

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)

Full Information

First Posted
December 15, 2020
Last Updated
September 27, 2021
Sponsor
Michael Reber
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1. Study Identification

Unique Protocol Identification Number
NCT04685824
Brief Title
Visual Telerehabilitation in AMD Patients
Official Title
Visual Rehabilitation in Macular Degeneration: a Pilot Study on Biofeedback Training and Home-based Mobile Virtual-reality Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Reber

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Visual rehabilitation, Oculus Go, Virtual-reality, Biofeedback

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Biofeedback Training + Immersive VR
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Biofeedback Training
Intervention Description
Audiovisual stimulation
Intervention Type
Device
Intervention Name(s)
Immersive Virtual-Reality
Intervention Description
Audiovisual stimulation
Primary Outcome Measure Information:
Title
Feasibility of home-based IVR audiovisual stimulation
Description
Feasibility objectives for our pilot study to be considered successful: Number of patients completing the stimulation protocol: ≥ 13 out of 16 patients (81%) per group. Number of IVR sessions performed by the patients to consider the stimulation protocol complete: ≥ 13 sessions out of 16 (81%). Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores < 25: ≤ 3 per patient during the treatment period. Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): ≤ 3 (19%) during the treatment period. Number of randomized patients per week: ≥ 3 patients.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
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)
Time Frame
from baseline to end of follow-up at 7 months
Title
Retinal Sensitivity
Description
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)
Time Frame
from baseline to end of follow-up at 7 months
Title
Fixation stability
Description
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)
Time Frame
from baseline to end of follow-up at 7 months
Title
Contrast Sensitivity
Description
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)
Time Frame
from baseline to end of follow-up at 7 months
Title
Reading Speed
Description
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)
Time Frame
from baseline to end of follow-up at 7 months
Title
Quality of Life Scores
Description
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)
Time Frame
from baseline to end of follow-up at 7 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Reber, PhD
Phone
416-634-7937
Email
michel.reber@uhnresearch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Daibert-Nido, MD
Email
monica.nido@uhn.ca
Facility Information:
Facility Name
Krembil Research Institute/Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 0S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Reber
Email
michael.reber@uhnresearch.ca
First Name & Middle Initial & Last Name & Degree
Monica Daibert-Nido
Email
monica.nido@uhn.ca

12. IPD Sharing Statement

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Visual Telerehabilitation in AMD Patients

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