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CompletedNCT04827147Updated Aug 19, 2026Results posted

Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia

An interventional study of Multi-Periscopic Prism (MPP) glasses and Fresnel Peripheral Prism (FPP) glasses in Homonymous Hemianopia, sponsored by Massachusetts Eye and Ear Infirmary. Completed at 8 sites in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
7 Years and older
Sex
All
01

Study 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).

Read the detailed description

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.

02

Conditions studied

  • Homonymous Hemianopia

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03

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    MPP first, FPP second

    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

  • Experimental
    FPP first, MPP second

    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

  • DeviceMulti-Periscopic Prism (MPP) glasses

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

  • DeviceFresnel Peripheral Prism (FPP) glasses

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

05

What researchers measure

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.

    Time frame: Immediately after each 4-week intervention

Secondary outcomes

  1. 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.

    Time frame: Immediately after each 4-week intervention

  2. Device Preference

    Number of participants selecting each device as a percentage of the total number of participants enrolled

    Time frame: Immediately after the second 4-week intervention

06

Results

Posted Mar 13, 2026

Participant flow

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.

First crossover period
Participant flow — First crossover period
MilestoneMPP First, FPP SecondFPP First, MPP Second
Started1820
Completed1717
Not completed13
Withdrew: Withdrawal by subject13
Second crossover period
Participant flow — Second crossover period
MilestoneMPP First, FPP SecondFPP First, MPP Second
Started1717
Completed1616
Not completed11
Withdrew: Withdrawal by subject11

Outcome measures

PrimaryImprovement 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.

Time frame:
Immediately after each 4-week intervention
Reported as:
Count of participants · Participants
Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 40 Degrees
ParticipantsAll Participants Who Were Allocated
Improved with MPPs12
Improved with FPPs10
Statistical analysis
  • All Participants Who Were Allocated · McNemar · p = = 0.75 · Diff between discordant pair proportions: 5 · 95% CI -14 to 24
SecondaryImprovement 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.

Time frame:
Immediately after each 4-week intervention
Reported as:
Count of participants · Participants
Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 20 Degrees
ParticipantsAll Participants Who Were Allocated
Improved with MPPs14
Improved with FPPs16
Statistical analysis
  • All Participants Who Were Allocated · McNemar · p = = 0.75 · Diff between discordant pair proportions: -5 · 95% CI -24 to 14
SecondaryDevice Preference

Number of participants selecting each device as a percentage of the total number of participants enrolled

Time frame:
Immediately after the second 4-week intervention
Reported as:
Count of participants · Participants
Device Preference
ParticipantsParticipants Who Completed the Crossover
Preferred MPPs13
Preferred FPPs19
Statistical analysis
  • Participants Who Completed the Crossover · Binomial confidence interval test · p = =0.38

Adverse events

Collected over From the start of the first 4-week intervention period to the end of the second 4-week intervention period, up to 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MPP All Participants0/38 (0%)0/38 (0%)0/38 (0%)
FPP All Participants0/38 (0%)0/38 (0%)0/38 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)MPP First, FPP SecondFPP First, MPP SecondTotal
Median57 (48 to 65)57 (34 to 69)57 (35 to 67)
Sex: Female, Male
Sex: Female, Male(Participants)MPP First, FPP SecondFPP First, MPP SecondTotal
Female4711
Male141327
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MPP First, FPP SecondFPP First, MPP SecondTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American426
White141529
More than one race000
Unknown or Not Reported033
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)MPP First, FPP SecondFPP First, MPP SecondTotal
Hispanic or Latino235
Not Hispanic or Latino161733
Unknown or Not Reported000
07

Study locations

8 sites
  • UAB Center for Low Vision Rehabilitation, Callahan Eye Hospital
    Birmingham, Alabama 35233, United States
  • 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
08

References and documents

Publications

  • 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. PubMed 42274646 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 12, 2025
  • Informed consent form · Jul 20, 2022
  • Informed consent form · Feb 11, 2022

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT04827147
Lead sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)
Responsible party
Eli Peli (Senior Scientist, Massachusetts Eye and Ear Infirmary) — Principal investigator
First posted
Apr 1, 2021
Start date
Apr 3, 2023
Primary completion
Apr 30, 2025
Completion
Apr 30, 2026
Results posted
Mar 13, 2026
Last update
Aug 19, 2026

Study contacts

Eli Peli, OD MSc
principal investigator · Schepens Eye Research Institute of Massachusetts Eye and Ear

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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