Blind Left Eye, Blind Right Eye, One Eye Blindness
Conditions
Keywords
Field expansion, Collision detection, Walking, Response time
Brief summary
The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular vision.
Interventions
DEVICEMultiplexing Prism
Multiplexing prism is designed for spatial vision multiplexing. It allows partial light transmission through the prism allow the observer to simultaneously see the physical world through the prism and see the shifted view from the non-seeing side. It is developed to expand the field of view of individuals with just one eye.
Sponsors
National Eye Institute (NEI)
Massachusetts Eye and Ear Infirmary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Individuals with Acquired Monocular Vision/ Blindness in One Eye
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* No medical health issues such as seizures, motor movements problem * Loss of vision in one eye (less than 20/200) for \>1 year) * Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction * No visual field defect in the seeing eye (nasal field of at least \>45degree) * No medical health issues such as seizures, motor movements problem
Exclusion criteria
* Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded * Any person with motor movements problem (e.g., unable to use extremities)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gain in Visual Field With the Multiplexing Prism | Visit 2 of Study (approximately 2-3 weeks after 1st Visit) | Field expansion is calculated based on the difference of the maximum field of view on the nasal side of the seeing/functioning eye (same side as the blind eye) with and without multiplexing prism. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Extent of Nasal Visual Field With the Multiplexing Prism | Visit 2 of Study (approximately 2-3 weeks after 1st Visit) | The farthest extent of the nasal visual field with the multiplexing prism placed in front of the seeing eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient's Demography Adult individual with acquired monocular vision (seeing with one eye) | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not qualify | 8 |
Baseline characteristics
| Characteristic | Patient's Demography |
|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Nasal Visual Field of the Seeing/Functioning Eye | 55 degree STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Gain in Visual Field With the Multiplexing Prism
Field expansion is calculated based on the difference of the maximum field of view on the nasal side of the seeing/functioning eye (same side as the blind eye) with and without multiplexing prism.
Time frame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amount of Visual Field Expansion | Gain in Visual Field With the Multiplexing Prism | 24 degrees | Standard Deviation 4 |
Secondary
Maximum Extent of Nasal Visual Field With the Multiplexing Prism
The farthest extent of the nasal visual field with the multiplexing prism placed in front of the seeing eye.
Time frame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amount of Visual Field Expansion | Maximum Extent of Nasal Visual Field With the Multiplexing Prism | 79 degrees | Standard Deviation 5 |