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Study was suspended 4/16/2020 due to global pandemic. Plans to restart or permanently end the study are still being evaluated.
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| Name | Class |
|---|---|
| Boston Biomedical Associates | OTHER |
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This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home environment. This study shall be carried out with individuals who have an implanted visual prosthesis device. There are no new implantations or changes to the original implant or external wearables being studied or tested. Additionally, data from the study shall not be used alter standard of care or the user's treatment options.
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| Measure | Description | Time Frame |
|---|---|---|
| Inter-observer reliability | Intraclass correlation coefficient (ICC) of the overall FLORA-20 scores provided by each of the assessors (in-person and remote) | Single 1 day visit |
| Intra-observer reliability | ICC of the overall FLORA-20 scores provided by the same assessor, assessed and re-assessed at two different time points | Single 1 day visit |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Average Performance, ON vs. OFF | Paired t-test to determine if there is a statistically significant improvement in average performance from ON vs. OFF | Single 1 day visit |
| Clinical Meaningfulness (Effect Size) |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 30 users with the Argus II or Orion system from the US will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Uday Patel, PhD | Second Sight Medical Products, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Sight Medical Products, Inc. | Sylmar | California | 91342 | United States |
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| ID | Term |
|---|---|
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Cohen's d calculation of overall FLORA-20 scores between device ON vs. OFF
| Single 1 day visit |
| Internal consistency - Cronbach's alpha | Cronbach's alpha of the individual FLORA-20 task scores | Single 1 day visit |
| Internal consistency - item-total correlations | Item-total correlations for each FLORA-20 task | Single 1 day visit |
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |