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Visual Telerehabilitation in AMD Patients

NCT ID: NCT04685824

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-10-06

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Degeneration

Keywords

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Visual rehabilitation Oculus Go Virtual-reality Biofeedback

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Biofeedback Training

Intervention Type DEVICE

Audiovisual stimulation

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).

Group Type EXPERIMENTAL

Biofeedback Training

Intervention Type DEVICE

Audiovisual stimulation

Immersive Virtual-Reality

Intervention Type DEVICE

Audiovisual stimulation

Interventions

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Biofeedback Training

Audiovisual stimulation

Intervention Type DEVICE

Immersive Virtual-Reality

Audiovisual stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michael Reber

OTHER

Sponsor Role lead

Responsible Party

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Michael Reber

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Krembil Research Institute/Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2020410013068

Identifier Type: -

Identifier Source: org_study_id