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Optical Device

Prism Glasses for Hemianopia

N/A
Recruiting
Led By Eli Peli, OD MSc
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Homonymous hemianopia with or without macular sparing for at least 6 months
Able to walk independently, using a cane or walker if needed
Must not have
Central visual field loss in the seeing hemifield of either eye (e.g. from macular degeneration, glaucoma, diabetic retinopathy or other maculopathies)
Significant cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests special glasses with powerful lenses to help people who have lost half of their vision on the same side in both eyes. The glasses work by bending light to expand their field of vision, making it easier to detect obstacles.

Who is the study for?
This trial is for individuals with homonymous hemianopia, which means they've lost half of their field of vision in both eyes. Participants must have at least 20/50 vision with correction, a refractive error within -12D to +5D, and be able to walk independently. They should not have conditions like dementia or significant cognitive impairment that would affect mobility or the use of prism glasses.
What is being tested?
The study is testing two types of prism glasses designed to expand the field of view: Multi-Periscopic Prism (MPP) glasses and Fresnel Peripheral Prism (FPP) glasses. The effectiveness of these glasses will be compared in helping patients navigate their environment.
What are the potential side effects?
Potential side effects may include discomfort adjusting to new visual perspectives, possible eye strain or headaches as users adapt to the prisms, and potential challenges with depth perception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had partial vision loss in both eyes for at least 6 months.
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I can walk on my own, even if I need a cane or walker.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have vision loss in part of my field of view due to an eye condition.
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I have significant difficulties with my memory or thinking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in detection rate for hazards approaching from the blind side in the VR walking simulator test
Secondary study objectives
Change in detection response time for hazards approaching from the blind side in the VR walking simulator test
Continuation rate (at end of crossover)
Continuation rate (long term)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MPP first, FPP secondExperimental Treatment2 Interventions
Participants in this arm will receive the MPP in the first period of the crossover and the FPP in the second period.
Group II: FPP first, MPP secondExperimental Treatment2 Interventions
Participants in this arm will receive the FPP in the first period of the crossover and the MPP in the second period.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
High-power prism glasses work by shifting images from the non-seeing side of the visual field to the seeing side, effectively expanding the field of view for patients with homonymous hemianopia. This is crucial for these patients as it helps them to better navigate their environment, avoid obstacles, and improve their overall quality of life. By redirecting light to the functional part of the retina, these glasses can significantly reduce the visual impairment caused by the loss of half the visual field in both eyes.
[Effect of infrared low-intensity laser therapy on orbital blood circulation in children with progressive short sightedness].

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
108 Previous Clinical Trials
12,969 Total Patients Enrolled
3 Trials studying Homonymous Hemianopia
65 Patients Enrolled for Homonymous Hemianopia
National Eye Institute (NEI)NIH
552 Previous Clinical Trials
1,406,923 Total Patients Enrolled
4 Trials studying Homonymous Hemianopia
138 Patients Enrolled for Homonymous Hemianopia
Eli Peli, OD MScPrincipal InvestigatorSchepens Eye Research Institute of Massachusetts Eye and Ear

Media Library

Fresnel Peripheral Prism (FPP) glasses (Optical Device) Clinical Trial Eligibility Overview. Trial Name: NCT04827147 — N/A
Homonymous Hemianopia Research Study Groups: MPP first, FPP second, FPP first, MPP second
Homonymous Hemianopia Clinical Trial 2023: Fresnel Peripheral Prism (FPP) glasses Highlights & Side Effects. Trial Name: NCT04827147 — N/A
Fresnel Peripheral Prism (FPP) glasses (Optical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04827147 — N/A
Homonymous Hemianopia Patient Testimony for trial: Trial Name: NCT04827147 — N/A
~5 spots leftby Jan 2025