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Active, Not Recruiting

NCT Number: NCT04827147

Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Center for Low Vision Rehabilitation, Callahan Eye Hospital, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Multi-Periscopic Prism (MPP) glasses

Device

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

Fresnel Peripheral Prism (FPP) glasses

Device

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

Primary outcomes

  1. Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 40 Degrees

    Time frame: Immediately after each 4-week intervention

    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.

Secondary outcomes

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

    Time frame: Immediately after each 4-week intervention

    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.

  2. Device Preference

    Time frame: Immediately after the second 4-week intervention

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

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2021
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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