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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY031777 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Field Expansion | Experimental | Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiplexing Prism | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 of Study (approximately 2-3 weeks after 1st Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 of Study (approximately 2-3 weeks after 1st Visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eli Peli, OD | Schepens Eye Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schepens Eye Research Institute | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30169357 | Background | Jung JH, Peli E. Field Expansion for Acquired Monocular Vision Using a Multiplexing Prism. Optom Vis Sci. 2018 Sep;95(9):814-828. doi: 10.1097/OPX.0000000000001277. | |
| 30169356 | Background | Jung JH, Peli E. No Useful Field Expansion with Full-field Prisms. Optom Vis Sci. 2018 Sep;95(9):805-813. doi: 10.1097/OPX.0000000000001271. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Participants for Multiplexing Prism | Of the 30 enrolled participants, 22 met the inclusion criteria and were prescribed with the multiplexing prism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient's Demography | Adult individual with acquired monocular vision (seeing with one eye) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | degrees | Visit 2 of Study (approximately 2-3 weeks after 1st Visit) |
|
|
The end of Visit 1 and Visit 2.
The intervention only involves a magnetic clip-on multiplexing prism that can be attached/removed easily from a pair of glasses, with minimal risks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient's Demography | Adult individuals with acquired monocular vision (seeing with one eye) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eli Peli | Schepens Eye Research Institute, Mass Eye and Ear | 617-912-2597 | eli_peli@meei.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2025 | Mar 31, 2025 | Prot_SAP_000.pdf |
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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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Individuals with Acquired Monocular Vision/ Blindness in One Eye
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|
| 28727615 | Background | Peli E, Jung JH. Multiplexing Prisms for Field Expansion. Optom Vis Sci. 2017 Aug;94(8):817-829. doi: 10.1097/OPX.0000000000001102. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Nasal Visual Field of the Seeing/Functioning Eye | Mean | Standard Deviation | degree |
|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | Visit 2 of Study (approximately 2-3 weeks after 1st Visit) |
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|
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |