Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Randomized Controlled Multicenter Clinical Trial of Multi-Periscopic Prism Glasses for Homonymous Hemianopia

Conditions
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Homonymous Hemianopia

Intervention / Treatment
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* Device: Multi-Periscopic Prism (MPP) glasses
* Device: Fresnel Peripheral Prism (FPP) glasses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Homonymous hemianopia with or without macular sparing for at least 6 months Visual acuity of at least 20/50 in each eye, with correction if needed Refractive error in the -12D to +5D range Able to walk independently, using a cane or walker if needed Able to communicate in English sufficiently to understand the study procedures and how to use the prisms Exclusion Criteria: Central visual field loss in the seeing hemifield of either eye (e.g. from macular degeneration, glaucoma, diabetic retinopathy or other maculopathies) Hemi-spatial neglect Significant cognitive impairment Dementia Any other physical or mental disabilities, or general health problems that could impair the ability to be independently mobile (i.e., walk ), participate in the VR walking simulator test or use the prism glasses

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPP first, FPP second<br>Participants in this arm will receive the MPP in the first period of the crossover and the FPP in the second period. | Device: Multi-Periscopic Prism (MPP) glasses<br>* Spectacles with multi-periscopic prisms mounted as oblique peripheral prism segments<br>Device: Fresnel Peripheral Prism (FPP) glasses<br>* Spectacles with conventional permanent Fresnel prisms mounted as oblique peripheral prism segments<br>|
| Experimental: FPP first, MPP second<br>Participants in this arm will receive the FPP in the first period of the crossover and the MPP in the second period. | Device: Multi-Periscopic Prism (MPP) glasses<br>* Spectacles with multi-periscopic prisms mounted as oblique peripheral prism segments<br>Device: Fresnel Peripheral Prism (FPP) glasses<br>* Spectacles with conventional permanent Fresnel prisms mounted as oblique peripheral prism segments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in detection rate for hazards approaching from the blind side in the VR walking simulator test | Number of pedestrians detected as a percentage of the total number of pedestrian events. | Baseline, After 4 weeks of wearing first pair of prism glasses, After 4 weeks of wearing second pair of prism glasses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in detection response time for hazards approaching from the blind side in the VR walking simulator test | Response time from pedestrian target onset to the first button press to indicate detection | Baseline, After 4 weeks of wearing first pair of prism glasses, After 4 weeks of wearing second pair of prism glasses | 
| Device preference | Number of participants selecting each device as a percentage of the total number of participants enrolled | After 4 weeks of wearing the second pair of prism glasses | 
| Continuation rate (at end of crossover) | Number of participants with a clinical decision to continue with prism glasses at the end of the crossover as a percentage of the total number of participants enrolled. | After 4 weeks of wearing the second pair of prism glasses | 
| Continuation rate (long term) | Number of participants still wearing prism glasses as a percentage of total number of participants enrolled. | At 6 months |