NCT04685824

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

December 15, 2020

Last Update Submit

November 27, 2023

Conditions

Macular Degeneration

Keywords

Visual rehabilitationOculus GoVirtual-realityBiofeedback

Outcome Measures

Primary Outcomes (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.

    18 months

Secondary Outcomes (6)

  • Visual Acuity

    from baseline to end of follow-up at 7 months

  • Retinal Sensitivity

    from baseline to end of follow-up at 7 months

  • Fixation stability

    from baseline to end of follow-up at 7 months

  • Contrast Sensitivity

    from baseline to end of follow-up at 7 months

  • Reading Speed

    from baseline to end of follow-up at 7 months

  • +1 more secondary outcomes

Study Arms (2)

Biofeedback Training

ACTIVE 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.

Device: Biofeedback Training

Biofeedback Training + Immersive VR

EXPERIMENTAL

* 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 TrainingDevice: Immersive Virtual-Reality

Interventions

Biofeedback TrainingDEVICE

Audiovisual stimulation

Biofeedback TrainingBiofeedback Training + Immersive VR
Immersive Virtual-RealityDEVICE

Audiovisual stimulation

Biofeedback Training + Immersive VR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Wet AMD.
  • Both eyes with media opacity that impairs microperimetry testing.
  • Inability to perform during testing and training.
  • Psychoactive drugs consumption.
  • History of vertigo or dizziness
  • Prior vision rehabilitation interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krembil Research Institute/Toronto Western Hospital

Toronto, Ontario, M5T 0S8, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 28, 2020

Study Start

September 15, 2021

Primary Completion

October 6, 2023

Study Completion

October 6, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

CA(1)