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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback Training | Active Comparator |
|
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| Biofeedback Training + Immersive VR | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback Training | Device | Audiovisual stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of home-based IVR audiovisual stimulation | Feasibility objectives for our pilot study to be considered successful:
| 18 months |
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krembil Research Institute/Toronto Western Hospital | Toronto | Ontario | M5T 0S8 | Canada |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Immersive Virtual-Reality | Device | Audiovisual stimulation |
|
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 |