Feasibility Tests for Various Prism Configurations for Visual Field Loss

September 22, 2025 updated by: Alexandra Bowers, Massachusetts Eye and Ear Infirmary

Visual Field Expansion Through Innovative Multi-Periscopic Prism Design

The investigators will develop and test different configurations of high-power prisms to expand the field of vision of patients with visual field loss to assist them with obstacle detection when walking. The study will involve multiple visits (typically four) to Schepens Eye Research Institute for fitting and testing with the prism glasses. The overall objective is to determine best designs and fitting parameters for implementation in prism devices for future clinical trials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Schepens Eye Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Visual field loss, either peripheral field loss or hemianopic field loss
  • Visual acuity of at least 20/50 in the better eye
  • In sufficiently good health to be able to complete sessions lasting 2-4 hours
  • Able to independently walk short distances
  • Able to give voluntary, informed consent
  • Able to speak English

Exclusion Criteria:

  • Any physical or mental impairments, including cognitive dysfunction, balance problems or other deficits that could impair the ability to walk or use the prism spectacles
  • A history of seizures in the last 6 months
  • Hemispatial neglect (subjects with hemianopic field loss only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High power prisms
Various configurations of high power prisms will be developed for each individual and custom fit into spectacles lenses.
Device: High power prisms
High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Field of view expansion
Time Frame: Through study completion, an average of four months
Horizontal and vertical extent of the expansion (in degrees) of the field of view
Through study completion, an average of four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pedestrian detection rate
Time Frame: Through study completion, an average of four months
Proportion of pedestrians detected (in simulated walking or simulated driving)
Through study completion, an average of four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Eye and Ear Infirmary

Collaborators

National Eye Institute (NEI)

Investigators

  • Study Director: Eliezer Peli, MSc, OD, Schepens Eye Research Institute of Massachusetts Eye and Ear

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2020

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPP_Feasibility1
  • R01EY023385 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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