Multiplexing Prism Fitting for Field Expansion of Monocular Vision

April 22, 2025 updated by: Eli Peli, Massachusetts Eye and Ear Infirmary

Monocular Visual Confusion for Field Expansion

The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular vision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • No medical health issues such as seizures, motor movements problem
  • Loss of vision in one eye (less than 20/200) for >1 year)
  • Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
  • No visual field defect in the seeing eye (nasal field of at least >45degree)
  • No medical health issues such as seizures, motor movements problem

Exclusion Criteria:

  • Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
  • Any person with motor movements problem (e.g., unable to use extremities)

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: Field Expansion
Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism
Device: Multiplexing Prism
Multiplexing prism is designed for spatial vision multiplexing. It allows partial light transmission through the prism allow the observer to simultaneously see the physical world through the prism and see the "shifted view" from the non-seeing side. It is developed to expand the field of view of individuals with just one eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gain in Visual Field With the Multiplexing Prism
Time Frame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
Field expansion is calculated based on the difference of the maximum field of view on the nasal side of the seeing/functioning eye (same side as the blind eye) with and without multiplexing prism.
Visit 2 of Study (approximately 2-3 weeks after 1st Visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Extent of Nasal Visual Field With the Multiplexing Prism
Time Frame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
The farthest extent of the nasal visual field with the multiplexing prism placed in front of the seeing eye.
Visit 2 of Study (approximately 2-3 weeks after 1st Visit)

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

  • Principal Investigator: Eli Peli, OD, Schepens Eye Research Institute

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)

December 27, 2023

Primary Completion (Actual)

October 22, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P001878
  • R01EY031777 (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

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.

Clinical Trials on One Eye Blindness

Clinical Trials on Multiplexing Prism

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe