Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia

NCT04827147 | Active Not Recruiting Results DMC FDA Device

• 2 other identifiers: MPPvsFPPR01EY023385
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 8

Brief Summary

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).

Conditions

Homonymous Hemianopia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 20 Degrees

  Immediately after each 4-week intervention

• Device Preference

  Immediately after the second 4-week intervention

Study Arms (2)

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.

Device: Multi-Periscopic Prism (MPP) glasses; Device: Fresnel Peripheral Prism (FPP) glasses

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.

Device: Multi-Periscopic Prism (MPP) glasses; Device: Fresnel Peripheral Prism (FPP) glasses

Interventions

Multi-Periscopic Prism (MPP) glasses DEVICE

Spectacles with multi-periscopic prisms mounted as oblique peripheral prism segments

FPP first, MPP second; MPP first, FPP second

Fresnel Peripheral Prism (FPP) glasses DEVICE

Spectacles with conventional permanent Fresnel prisms mounted as oblique peripheral prism segments

FPP first, MPP second; MPP first, FPP second

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Homonymous hemianopia with or without macular sparing for at least 3 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• National Eye Institute (NEI): collaborator

Study Sites (8)

UAB Center for Low Vision Rehabilitation, Callahan Eye Hospital

Birmingham, Alabama, 35233, United States

Location

UCHealth Sue Anschutz-Rodgers Eye Center

Denver, Colorado, 80045, United States

Location

Visual Health and Surgical Center

Palm Springs, Florida, 33461, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

Schepens Eye Research Institute

Boston, Massachusetts, 02114, United States

Location

New England College of Optometry

Boston, Massachusetts, 02215, United States

Location

The Eye and Vision Center at MCPHS

Worcester, Massachusetts, 01608, United States

Location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Hemianopsia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Alex Bowers
• Organization: Schepens Eye Research Institute of Mass Eye and Ear

alex_bowers@meei.harvard.edu

617 912 2512

Study Officials

• Eli Peli, OD MSc

  Schepens Eye Research Institute of Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: October 3, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2025-06

Locations

US (8)