Visual Telerehabilitation in AMD Patients

Study Overview
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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.

Official Title
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Visual Rehabilitation in Macular Degeneration: a Pilot Study on Biofeedback Training and Home-based Mobile Virtual-reality Stimulation

Conditions
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Macular Degeneration

Intervention / Treatment
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* Device: Biofeedback Training
* Device: Immersive Virtual-Reality


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biofeedback Training<br>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<br>* Audiovisual stimulation<br>|
| Experimental: Biofeedback Training + Immersive VR<br>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<br>* Audiovisual stimulation<br>Device: Immersive Virtual-Reality<br>* Audiovisual stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | from baseline to end of follow-up at 7 months | 
| 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) | from baseline to end of follow-up at 7 months | 
| 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) | from baseline to end of follow-up at 7 months | 
| 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) | from baseline to end of follow-up at 7 months | 
| 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) | from baseline to end of follow-up at 7 months | 
| 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) | from baseline to end of follow-up at 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual rehabilitation, Oculus Go, Virtual-reality, Biofeedback