Macular Degeneration
Conditions
Keywords
Visual rehabilitation, Oculus Go, Virtual-reality, Biofeedback
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.
Interventions
DEVICEBiofeedback Training
Audiovisual stimulation
DEVICEImmersive Virtual-Reality
Audiovisual stimulation
Sponsors
Michael Reber
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of home-based IVR audiovisual stimulation | 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | from baseline to end of follow-up at 7 months | 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 | from baseline to end of follow-up at 7 months | 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) |
| Quality of Life Scores | from baseline to end of follow-up at 7 months | 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) |
| Contrast Sensitivity | from baseline to end of follow-up at 7 months | 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 | from baseline to end of follow-up at 7 months | 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) |
| Fixation stability | from baseline to end of follow-up at 7 months | 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) |
Countries
Canada
Outcome results
None listed