NCT06027216

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 8, 2025

Completed
Last Updated

May 8, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

August 29, 2023

Results QC Date

March 31, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

Field expansionCollision detectionWalkingResponse time

Outcome Measures

Primary Outcomes (1)

  • Gain in Visual Field With the Multiplexing Prism

    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 Outcomes (1)

  • Maximum Extent of Nasal Visual Field With the Multiplexing Prism

    Visit 2 of Study (approximately 2-3 weeks after 1st Visit)

Study Arms (1)

Field Expansion

EXPERIMENTAL

Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism

Device: Multiplexing Prism

Interventions

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.

Field Expansion

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schepens Eye Research Institute

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • Jung JH, Peli E. Field Expansion for Acquired Monocular Vision Using a Multiplexing Prism. Optom Vis Sci. 2018 Sep;95(9):814-828. doi: 10.1097/OPX.0000000000001277.

    PMID: 30169357BACKGROUND
  • Jung JH, Peli E. No Useful Field Expansion with Full-field Prisms. Optom Vis Sci. 2018 Sep;95(9):805-813. doi: 10.1097/OPX.0000000000001271.

    PMID: 30169356BACKGROUND
  • Peli E, Jung JH. Multiplexing Prisms for Field Expansion. Optom Vis Sci. 2017 Aug;94(8):817-829. doi: 10.1097/OPX.0000000000001102.

    PMID: 28727615BACKGROUND

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Eli Peli
Organization
Schepens Eye Research Institute, Mass Eye and Ear

Study Officials

  • Eli Peli, OD

    Schepens Eye Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Individuals with Acquired Monocular Vision/ Blindness in One Eye
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 7, 2023

Study Start

December 27, 2023

Primary Completion

October 22, 2024

Study Completion

December 31, 2024

Last Updated

May 8, 2025

Results First Posted

May 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations