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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY023385 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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This clinical trial will evaluate the efficacy of two types of high-power prism glasses that provide field of view expansion for patients with homonymous hemianopia (the complete loss of half the field of vision on the same side in both eyes).
Patients with hemianopic field loss may be unaware of objects in their blind (non-seeing) hemi-field and often experience difficulties with hazards, such as walking into obstacles on the side of the field loss. Prism glasses that provide field of view expansion may be helpful in detecting hazards on the blind side. In this clinical trial, two types of high power prism glasses will be evaluated. A new design of prisms, Multi-Periscopic Prisms (MPP), will be compared to commercially-available permanent Fresnel peripheral prism (FPP) glasses. The extent to which the prismatic devices improve detection of hazards on the side of the field loss and are helpful when walking will be evaluated.
Participants will try each type of prism glasses at home for 4 weeks in counterbalanced order. Prism glasses will be fitted by Low Vision Practitioners at vision rehabilitation clinics. Participants will attend in-office study visits before and after wearing each type of prism glasses. At the in-office visits they will complete a test that involves detecting pedestrian hazards in a video simulating a walk through a busy shopping mall (virtual reality, VR, walking simulator test). In addition, they may be asked to complete questionnaires to record their experiences of using the prism glasses.
After wearing the second pair of prism glasses, participants will be asked to complete a questionnaire comparing the two types of prism glasses and to select their preferred type. A clinical decision will be made as to whether the participant should continue to use either the first or second pair of prism glasses (e.g. if a participant finds one pair of prism glasses helpful for obstacle avoidance when walking). For participants who continue with the prism glasses, telephone follow-up interviews will be conducted after about 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPP first, FPP second | Experimental | Participants in this arm will receive the MPP in the first period of the crossover and the FPP in the second period. |
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| FPP first, MPP second | Experimental | Participants in this arm will receive the FPP in the first period of the crossover and the MPP in the second period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Periscopic Prism (MPP) glasses | Device | Spectacles with multi-periscopic prisms mounted as oblique peripheral prism segments |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 40 Degrees | Improvement in detection rate with prism glasses for hazards approaching from the blind side at a bearing angle of 40 degrees in the VR walking simulator test. Improvement is a binary outcome, defined as blind-side detection rate (number of pedestrians detected as a percentage of the total number of pedestrian events) which is significantly higher (z-test for two proportions) with than without prism glasses at the same visit. | Immediately after each 4-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 20 Degrees | Improvement in detection rate with prism glasses for hazards approaching from the blind side at a bearing angle of 20 degrees in the VR walking simulator test. Improvement is a binary outcome, defined as blind-side detection rate (number of pedestrians detected as a percentage of the total number of pedestrian events) which is significantly higher (z-test for two proportions) with than without prism glasses at the same visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eli Peli, OD MSc | Schepens Eye Research Institute of Massachusetts Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Center for Low Vision Rehabilitation, Callahan Eye Hospital | Birmingham | Alabama | 35233 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42274646 | Derived | Bowers AR, Manda S, Shekar S, Hwang AD, Jung JH, Peli E. A randomized crossover clinical trial of multi-periscopic and Fresnel peripheral prism glasses for hemianopia. Optom Vis Sci. 2026 Jun;103(6):e70072. doi: 10.1002/ovs2.70072. |
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64 participants were screened. 26 did not meet eligibility criteria and were excluded All 38 participants who met eligibility criteria were allocated to receive either MPP first (n=19) or FPP first (n=19). One allocation was mistakenly swopped; therefore 18 participants started in the MPP first group and 20 in the FPP first group.
Participants were recruited between April 2023 and November 2024 at seven vision rehabilitation clinics in the United States, including three university clinics, three academic medical centers and one private practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | MPP First, FPP Second | Participants in this arm received the MPP in the first period of the crossover and the FPP in the second period. |
| FG001 | FPP First, MPP Second | Participants in this arm received the FPP in the first period of the crossover and the MPP in the second period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First crossover period |
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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 | Jun 12, 2025 |
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| Fresnel Peripheral Prism (FPP) glasses | Device | Spectacles with conventional permanent Fresnel prisms mounted as oblique peripheral prism segments |
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| Immediately after each 4-week intervention |
| Device Preference | Number of participants selecting each device as a percentage of the total number of participants enrolled | Immediately after the second 4-week intervention |
| UCHealth Sue Anschutz-Rodgers Eye Center |
| Denver |
| Colorado |
| 80045 |
| United States |
| Visual Health and Surgical Center | Palm Springs | Florida | 33461 | United States |
| Illinois College of Optometry | Chicago | Illinois | 60616 | United States |
| Schepens Eye Research Institute | Boston | Massachusetts | 02114 | United States |
| New England College of Optometry | Boston | Massachusetts | 02215 | United States |
| The Eye and Vision Center at MCPHS | Worcester | Massachusetts | 01608 | United States |
| UMass Chan Medical School | Worcester | Massachusetts | 01655 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Second crossover period |
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| ID | Title | Description |
|---|---|---|
| BG000 | MPP First, FPP Second | Participants in this arm received the MPP in the first period of the crossover and the FPP in the second period. |
| BG001 | FPP First, MPP Second | Participants in this arm received the FPP in the first period of the crossover and the MPP in the second period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 40 Degrees | Improvement in detection rate with prism glasses for hazards approaching from the blind side at a bearing angle of 40 degrees in the VR walking simulator test. Improvement is a binary outcome, defined as blind-side detection rate (number of pedestrians detected as a percentage of the total number of pedestrian events) which is significantly higher (z-test for two proportions) with than without prism glasses at the same visit. | Posted | Count of Participants | Participants | Immediately after each 4-week intervention |
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| Secondary | Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 20 Degrees | Improvement in detection rate with prism glasses for hazards approaching from the blind side at a bearing angle of 20 degrees in the VR walking simulator test. Improvement is a binary outcome, defined as blind-side detection rate (number of pedestrians detected as a percentage of the total number of pedestrian events) which is significantly higher (z-test for two proportions) with than without prism glasses at the same visit. | Posted | Count of Participants | Participants | Immediately after each 4-week intervention |
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| Secondary | Device Preference | Number of participants selecting each device as a percentage of the total number of participants enrolled | Posted | Count of Participants | Participants | Immediately after the second 4-week intervention |
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From the start of the first 4-week intervention period to the end of the second 4-week intervention period, up to 8 weeks
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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 | MPP All Participants | All participants who wore MPP glasses | 0 | 38 | 0 | 38 | 0 | 38 |
| EG001 | FPP All Participants | All participants who wore FPP glasses | 0 | 38 | 0 | 38 | 0 | 38 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex Bowers | Schepens Eye Research Institute of Mass Eye and Ear | 617 912 2512 | alex_bowers@meei.harvard.edu |
| Jan 29, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent form | Jul 20, 2022 | Jan 29, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent form (children under 14 years) | Feb 11, 2022 | Jan 29, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001766 | Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Denominators |
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| Categories |
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| Preferred MPPs |
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| Preferred FPPs |
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