Visual Telerehabilitation in AMD Patients

Michael Reber

Status: Terminated

Conditions: Macular Degeneration

Treatments: Device: Biofeedback Training; Device: Immersive Virtual-Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT04685824

2020410013068

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Biofeedback Training

Active Comparator group

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.

Treatment:

Device: Biofeedback Training

Biofeedback Training + Immersive VR

Experimental group

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).

Treatment:

Device: Immersive Virtual-Reality

Device: Biofeedback Training